Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.

Start Date18 Aug 2025

Sponsor / Collaborator

National Cancer Institute

NCT06806852

/ Not yet recruitingPhase 1

A Phase Ib Open Label Randomised Clinical Trial to Evaluate Safety and Efficacy of BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Compared With Pembrolizumab Monotherapy for the First-line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer.
The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing.
Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site.
Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Start Date01 May 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06855212

/ RecruitingPhase 2IIT

A Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for Head and Neck Squamous Cell Carcinoma

The purpose of the study is to determine if cemiplimab in combination with cetuximab given before their surgery are beneficial and safe in participants with head and neck squamous cell carcinoma (HNSCC).

Start Date20 Mar 2025

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+2]

100 Clinical Results associated with Cetuximab

100 Translational Medicine associated with Cetuximab

100 Patents (Medical) associated with Cetuximab

8,599

Literatures (Medical) associated with Cetuximab

01 Dec 2025·Journal of Gastrointestinal Cancer

Anti-EGFR Rechallenge in Metastatic Colorectal Cancer and the Role of ctDNA: A Systematic Review and Meta-analysis

Review

Author: da Silva, Luís Felipe Leite ; Peixoto, Renata D 'Alpino ; Saldanha, Erick Figueiredo ; da Conceição, Lucas Diniz ; Noronha, Mariana Macambira ; da Silva, Marcos Vinícius Martins Grangeiro

BACKGROUND:

Metastatic colorectal cancer (mCRC) remains a significant clinical challenge. While anti-EGFR inhibitors have improved survival rates, their long-term efficacy is limited by disease progression, which is often associated with the development of acquired resistance mutations. However, some patients may regain sensitivity to anti-EGFR agents after alternative therapies, suggesting a potential benefit for rechallenge strategies. Our study aims to conduct a systematic review and meta-analysis to comprehensively evaluate the efficacy and safety of EGFR rechallenge in patients with mCRC.

METHODS:

A systematic search of the MEDLINE, EMBASE, and Cochrane databases was conducted between October 28 and December 24, 2023, to identify clinical trials investigating treatment regimens incorporating panitumumab or cetuximab as a rechallenge strategy. Pooled proportions or hazard ratios (HR) were calculated using a random effects model. Inter-study heterogeneity was assessed using the I².

RESULTS:

Among the 2105 articles identified through the search, 13 met the predetermined inclusion criteria. Of these, 12 were phase II studies, encompassing 92.3% of the patient population. Cetuximab was administered to 302 patients (75.1%), whereas panitumumab was utilized in 100 patients (24.9%).A pooled analysis of eight studies demonstrated an objective response rate of 20.50% (95% CI 7.94 to 33.07) and a disease control rate of 67.35% (95% CI 58.60 to 76.09). The median progression-free survival was estimated at 3.5 months (95% CI 2.68-6.69), with a median OS of 9.8 months (95% CI 6.71-12.89). Patients exhibiting RAS wild-type status in circulating tumor DNA (ctDNA) analysis derived enhanced benefits from anti-EGFR rechallenge (HR: 0.41; 95% CI 0.28-0.60, I² = 60%). Common grade 3 or higher treatment-related adverse events included neutropenia (22.8%) and rash (14.9%).

CONCLUSION:

This meta-analysis underscores the efficacy and safety of anti-EGFR rechallenge as a promising therapeutic approach for a subset of patients afflicted with mCRC. The observed correlation between wild-type RAS status, as determined through ctDNA analysis, and improved OS signals the prospect of precision oncology in guiding treatment decisions.

01 Dec 2025·Journal of Gastrointestinal Cancer

Efficacy and Safety of Anti-EGFR Therapy Rechallenge in Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis

Review

Author: Burbano, Rommel Mario Rodríguez ; de Oliveira Rodrigues, Anna Luíza Soares ; de Moraes, Francisco Cezar Aquino ; Limachi-Choque, Jhonny ; Priantti, Jonathan N

BACKGROUND:

Colorectal cancer (CRC) represents the second leading cause of cancer-related mortality worldwide, with a significant portion of patients presenting with metastatic disease at diagnosis. Resistance to initial anti-EGFR therapy, a key treatment for RAS wild-type metastatic CRC, remains a major challenge. This study aimed to assess the efficacy and safety of rechallenge with anti-EGFR therapy in patients with metastatic CRC who have progressed after prior treatments.

METHODS:

A systematic search was conducted across PubMed, Web of Science, Cochrane, and Scopus. Studies were included if they were randomized controlled trials (RCTs) or observational studies involving patients with EGFR-mutated metastatic CRC who received anti-EGFR therapy as a rechallenge. Endpoints included objective response rate (ORR), disease control rate (DCR), and the incidence of adverse events. Statistical analyses were performed using the DerSimonian/Laird random effect model, with heterogeneity assessed via I² statistics. R, version 4.2.3, was used for statistical analyses.

RESULTS:

Fourteen studies were included with 520 patients; 50.3% were male, and the median age was 63 years old. The median progression-free survival (mPFS) ranged between 2.4 and 4.9 months, while the median overall survival (mOS) ranged from 5 to 17.8 months. Our pooled analysis demonstrated an objective response rate (ORR) of 17.70% (95% CI, 8.58-26.82%) and a disease control rate (DCR) of 61.72% (95% CI, 53.32-70.11%), both with significant heterogeneity (I², 84% and 80%, respectively; p < 0.01). In the subgroup analysis, cetuximab showed an ORR of 18.31% (95% CI, 4.67-31.94%), and panitumumab an ORR of 10.9% (95% CI, 0.00-26.82%), while the combination of both resulted in an ORR of 29.24% (95% CI, 0.00-65.84%). For DCR, cetuximab resulted in 62.1% (95% CI, 49.32-74.87%), panitumumab in 63.05% (95% CI, 52.13-73.97%), and the combination in 60.34% (95% CI, 31.92-88.77%), all with significant heterogeneity. Adverse events included anemia (15.39%), diarrhea (4.20%), hypomagnesemia (6.40%), neutropenia (22.57%), and skin rash (13.22%).

CONCLUSIONS:

Rechallenge with anti-EGFR therapy in metastatic CRC patients shows moderate efficacy with manageable safety profiles. These findings highlight the need for careful patient selection and monitoring to optimize outcomes. Further studies are warranted to refine strategies for maximizing the therapeutic benefits of anti-EGFR rechallenge.

01 May 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Efficacy and safety of PD-1/PD-L1 inhibitors combined with standard of care for locally advanced head and neck squamous cell carcinoma: A meta-analysis of randomized controlled trials

Review

Author: Chen, Long ; Yin, Shi-Hua ; Mo, Dun-Chang ; Peng, Li-Ping ; Zhao, Shi-Jie ; He, Jin-Nian

OBJECTIVES:

Chemoradiotherapy (CRT) or radiotherapy (RT) combined with cetuximab (for cisplatin-ineligible patients) is the standard of care (SoC) for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This study investigates whether adding programmed cell death-1/programmed cell death-ligand 1 (PD-1/PD-L1) immune checkpoint inhibitors (ICIs) to standard therapy improves survival in patients with LA-HNSCC.

METHODS:

A comprehensive search of PubMed, Embase, and the Cochrane Library identified randomized controlled trials (RCTs) evaluating PD-1/PD-L1 inhibitors plus SoC compared with SoC alone for LA-HNSCC. The primary endpoints were progression-free survival (PFS), overall survival (OS), locoregional event-free survival (LEFS), and distant metastasis-free survival (DMFS) at the 1-year and 2-year time points, as well as the incidence of grade 3 or higher adverse events (AEs).

RESULTS:

Four RCTs encompassing 1818 patients met the inclusion criteria. Compared with SoC alone, PD-1/PD-L1 inhibitors combined with SoC did not significantly improve 1-year or 2-year PFS, OS, LEFS, or DMFS (all p > 0.05). Subgroup analyses further showed no survival benefit at 2 years in the ICI + CRT, ICI + RT-cetuximab, anti-PD-1, or anti-PD-L1 subgroups. Additionally, there was no statistically significant difference in the incidence of grade 3 or higher AEs between the combined and SoC-only groups (p = 0.69).

CONCLUSIONS:

These findings suggest that adding PD-1/PD-L1 inhibitors to standard therapy does not enhance 1-year or 2-year survival for patients with LA-HNSCC, and confers a similar severe safety profile.

492

News (Medical) associated with Cetuximab

17 Mar 2025

·ir.nanobiotix.com

NANOBIOTIX Strengthens Financial Position Through Amendment of Global Licensing Agreement for JNJ-1900 (NBTXR3) and Extends Cash Visibility to Mid-2026

PARIS and CAMBRIDGE, Mass., March 17, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering disruptive nanotherapeutic approaches to revolutionize treatment outcomes for millions of patients, today announced the execution of another disciplined step in its financial strategy through the amendment of the Company’s global licensing agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company. The amendment removes Nanobiotix’s funding obligation for NANORAY-312 and releases Johnson & Johnson from select future potential milestone payments, while safeguarding Nanobiotix’s path to sustainable cashflow through significant potential milestone payments. Core Components of the Amendment Johnson & Johnson to Cover NANORAY-312 Costs Through Completion: Johnson & Johnson will assume nearly all remaining costs for the ongoing pivotal Phase 3 trial through completion, less a small portion of costs that will remain covered by Nanobiotix. Johnson & Johnson will assume nearly all remaining costs for the ongoing pivotal Phase 3 trial through completion, less a small portion of costs that will remain covered by Nanobiotix. Overall Deal Value Adjusted from Approximately $2.7B to Approximately $2.6B: Revisions to potential future milestone payments in the amendment total $105M while maintaining first significant milestones and hundreds of millions in potential milestone payments related to the clinical programs for cisplatin-ineligible head and neck cancer and stage 3 unresectable non-small cell lung cancer expected by Nanobiotix in the coming years. The global licensing agreement, now valued up to approximately $2.6B, includes Nanobiotix eligibility for potential success-based payments that include: $1.77B, in the aggregate, in potential development, regulatory, and sales milestones related to the first programs including cisplatin-ineligible head and neck cancer and unresectable stage 3 non-small cell lung cancer. $650M, in the aggregate, in potential additional development, regulatory, and sales milestones related to five new indications that may be developed by Johnson & Johnson at its sole discretion. $165M, in the aggregate, in potential development, regulatory, and sales milestones for China, South Korea, Singapore, and Thailand. In addition to the approximately $2.6B in potential milestones outlined above, Nanobiotix remains eligible for $220M in potential development and regulatory milestones per new indication that may be developed by Nanobiotix, in alignment with Johnson & Johnson. Tiered double-digit potential royalties in the low 10s to low 20s remain unchanged. Revisions to potential future milestone payments in the amendment total $105M while maintaining first significant milestones and hundreds of millions in potential milestone payments related to the clinical programs for cisplatin-ineligible head and neck cancer and stage 3 unresectable non-small cell lung cancer expected by Nanobiotix in the coming years. The global licensing agreement, now valued up to approximately $2.6B, includes Nanobiotix eligibility for potential success-based payments that include: $1.77B, in the aggregate, in potential development, regulatory, and sales milestones related to the first programs including cisplatin-ineligible head and neck cancer and unresectable stage 3 non-small cell lung cancer. $650M, in the aggregate, in potential additional development, regulatory, and sales milestones related to five new indications that may be developed by Johnson & Johnson at its sole discretion. $165M, in the aggregate, in potential development, regulatory, and sales milestones for China, South Korea, Singapore, and Thailand. In addition to the approximately $2.6B in potential milestones outlined above, Nanobiotix remains eligible for $220M in potential development and regulatory milestones per new indication that may be developed by Nanobiotix, in alignment with Johnson & Johnson. Tiered double-digit potential royalties in the low 10s to low 20s remain unchanged. $1.77B, in the aggregate, in potential development, regulatory, and sales milestones related to the first programs including cisplatin-ineligible head and neck cancer and unresectable stage 3 non-small cell lung cancer. $650M, in the aggregate, in potential additional development, regulatory, and sales milestones related to five new indications that may be developed by Johnson & Johnson at its sole discretion. $165M, in the aggregate, in potential development, regulatory, and sales milestones for China, South Korea, Singapore, and Thailand. Meaningful Extension of Cash Runway and Reduction of Cash Burn: The amended agreement has enabled Nanobiotix to strengthen its financial position, extending cash visibility to mid-2026, while continuing to explore additional financing options—preferably non-dilutive—to further extend runway into 2027. Nanobiotix also expects a meaningful reduction of operational cash burn going forward, as the ongoing Phase 3 study previously represented a significant portion of the Company’s operating costs. The amended agreement has enabled Nanobiotix to strengthen its financial position, extending cash visibility to mid-2026, while continuing to explore additional financing options—preferably non-dilutive—to further extend runway into 2027. Nanobiotix also expects a meaningful reduction of operational cash burn going forward, as the ongoing Phase 3 study previously represented a significant portion of the Company’s operating costs. “Our disciplined financial approach has provided an important step and continues our positive trend toward long-term stability and profitability,” said Bart Van Rhijn, Nanobiotix Chief Financial and Business Officer. “The revised licensing terms with Johnson & Johnson ensure operational alignment given changes in NANORAY-312 responsibilities while preserving key milestone opportunities and extending Nanobiotix cash visibility into mid-2026. We are pleased by what we view as a favorable cost of capital resulting from this amendment. We are continuing to evaluate additional, preferably non-dilutive, financial solutions to further extend runway into 2027 and ensure our path to sustainable revenue through the hundreds of millions in potential milestone payments related to our lead programs expected in the coming years.” Conference Call and Webcast Nanobiotix will host a conference call and live audio webcast on Tuesday, March 18, 2025, at 8:30 AM EDT / 1:30 PM CET, prior to the open of the U.S. market. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial and business officer, will briefly review the amendment and its impact on the Company before taking questions from participants. Registration and conference call link: click here Details of the call are also available in the investors section of the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior the event start. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website. Participants are invited to email their questions in advance to investors@nanobiotix.com. About JNJ-1900 (NBTXR3) NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024, in Nanobiotix’ 2024 semi-annual report under the caption “Supplemental Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18, 2024, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts Attachment 2025-03-17 -- NBTX -- Amends Global Licensing Agmt JNJ-1900 -- FINAL

Phase 3License out/inFast Track

10 Mar 2025

·investors.biontech.de

BioNTech Announces Fourth Quarter and Full Year 2024 Financial Results and Corporate Update

Advanced oncology pipeline including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator candidate BNT327 and mRNA cancer immunotherapies Multiple data readouts expected in 2025 and 2026 aimed at providing clinical proof of BioNTech’s pipeline strategy and advancing the Company towards becoming a diversified multi-product oncology portfolio company by 2030 Completed acquisition of Biotheus securing full control of next-generation immunomodulator candidate BNT327, a bispecific antibody targeting PD-L1 and VEGF-A1 Successfully launched JN.1- and KP.2-adapted COVID-19 vaccines across different countries and regions and maintained global market leadership Fourth quarter and full year 2024 revenues of €1.2 billion and €2.8 billion**, respectively Full year 2024 net loss of €0.7 billion and diluted loss per share of €2.77 ($3.00)1 Cash and cash equivalents plus security investments of €17.4 billion as of December 31, 20242 Expects 2025 total revenues between €1.7 billion and €2.2 billion Conference call and webcast scheduled for March 10, 2025, at 8:00 a.m. EDT (1:00 p.m. CET) MAINZ, Germany, March 10, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three months and full year ended December 31, 2024, and provided an update on its corporate progress. “From the very beginning, BioNTech’s vision has been to translate our science into survival and become an immunotherapy powerhouse. In 2024, we made significant progress towards our vision through important oncology pipeline advancements, including the initiation of global Phase 3 clinical trials for our anti-PD-L1/VEGF-A bispecific antibody candidate BNT327 and key data updates from our mRNA cancer immunotherapy programs,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “We expect 2025 to be a data-rich year with multiple important updates from our priority programs, which we believe have disruptive potential and could improve the standard of care, if successfully developed and approved.” Financial Review for Fourth Quarter and Full Year 2024 Financial Results Total revenues reported were €1,190.0 million for the three months ended December 31, 2024, compared to €1,479.0 million for the comparative prior year period. For the year ended December 31, 2024, revenues were €2,751.1 million, compared to €3,819.0 million for the comparative prior year period. The decrease in revenues was primarily driven by lower sales of the Company’s COVID-19 vaccines due to reduced market demand. In addition, write-downs by BioNTech’s collaboration partner Pfizer Inc. (“Pfizer”) significantly reduced the Company’s gross profit share which negatively influenced its revenues. Cost of sales were €243.5 million for the three months ended December 31, 2024, compared to €179.1 million for the comparative prior year period. For the year ended December 31, 2024, cost of sales were €541.3 million, compared to €599.8 million for the comparative prior year period. Cost of sales were influenced by COVID-19 vaccine sales and inventory write-downs and scrapping. Research and development (“R&D”) expenses were €611.8 million for the three months ended December 31, 2024, compared to €577.8 million for the comparative prior year period. For the year ended December 31, 2024, R&D expenses were €2,254.2 million, compared to €1,783.1 million for the comparative prior year period. R&D expenses were mainly influenced by advancing clinical studies for the Company’s late-stage oncology product candidates. Further contributions to the increase came from higher personnel expenses resulting from an increase in headcount. Sales, general and administrative (“SG&A”)3 expenses, in total, amounted to €132.1 million for the three months ended December 31, 2024, compared to €142.3 million for the comparative prior year period. For the year ended December 31, 2024, SG&A expenses were €599.0 million, compared to €557.7 million for the comparative prior year period. SG&A expenses were mainly influenced by the setup and enhancement of commercial IT platforms and personnel expenses resulting from an increase in headcount. Other operating results amounted to negative €54.0 million during the three months ended December 31, 2024, compared to negative €53.6 million for the comparative prior year period. For the year ended December 31, 2024, other operating result amounted to negative €670.9 million compared to negative €188.0 million for the prior year period. The decrease was mainly due to the settlement of contractual disputes and related expenses to such disputes and other litigations. The amounts for contractual disputes are net of the related reimbursements expected to be received. Income taxes were accrued with an amount of €41.7 million in tax expenses for the three months ended December 31, 2024, compared to €205.3 million in accrued tax expenses for the comparative prior year period. For the year ended December 31, 2024, income taxes were realized with an amount of €12.4 million in tax income for the year ended December 31, 2024, compared to €255.8 million of accrued tax expenses for the comparative prior year period. Net profit was €259.5 million for the three months ended December 31, 2024, compared to €457.9 million net profit for the comparative prior year period. For the year ended December 31, 2024, net loss was €665.3 million, compared to a net profit of €930.3 million for the comparative prior year period. Cash and cash equivalents plus security investments2 as of December 31, 2024, reached €17,359.2 million, comprising of €9,761.9 million in cash and cash equivalents, €6,536.2 million in current security investments and €1,061.1 million in non-current security investments. Diluted earnings per share was €1.08 for the three months ended December 31, 2024, compared to €1.88 for the comparative prior year period. For the year ended December 31, 2024, diluted loss per share was €2.77, compared to diluted earnings per share of €3.83 for the comparative prior year period.Shares outstanding as of December 31, 2024, were 239,970,804, excluding 8,581,396 shares held in treasury. “Through strategic investments in our priority programs like our next-generation immunomodulator candidate BNT327, we strive to meaningfully improve treatments for patients,” said Jens Holstein, CFO of BioNTech. “Our strong financial position enables us to fuel our R&D activities and to prepare for multiple product launches in the coming years. With our targeted investments we aim to create long-term value for the benefit of BioNTech’s stakeholders.” 2025 Financial Year Guidance4 BioNTech expects its revenues for the full 2025 financial year to be in the range of €1,700 - €2,200 million and revenue phasing similar to 2024, primarily concentrated in the last three to four months, driving the full year revenue figure. The revenue guidance assumes: relatively stable vaccination rates, pricing levels and market share compared to 2024; estimated inventory write-downs and other charges by BioNTech’s collaboration partner Pfizer that negatively influence BioNTech’s revenues; anticipated revenues from a pandemic preparedness contract with the German government; and anticipated revenues from the BioNTech Group service businesses. Planned 2025 Financial Year Expenses and Capex BioNTech expects to continue to focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while continuing to be cost disciplined. Strategic capital allocation will remain a key driver of the Company’s trajectory. As part of BioNTech’s strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and create future value. The full audited consolidated financial statements as of and for the year ended December 31, 2024, can be found in BioNTech’s Annual Report on Form 20-F filed today with the United States Securities and Exchange Commission (“SEC”) and available at www.sec.gov. Endnotes1 Calculated applying the average foreign exchange rate for the year ended December 31, 2024, as published by the German Central Bank (Deutsche Bundesbank). 2 Payments associated with the closing of the Biotheus acquisition and with the resolved settlement of a contractual dispute with the National Institutes of Health (“NIH”) are expected to result in a cash outflow of approximately $1.6 billion to be reflected in cash & cash equivalents in the Company’s first quarter 2025 financial results. The settlement payment of $467 million related to a contractual dispute with the University of Pennsylvania is expected to be reflected in the Company’s second quarter 2025 financial results. In connection with these settlements, BioNTech expects to be reimbursed approximately $535 million by its partner during 2025 and 2026. 3 Sales, general and administrative expenses (“SG&A”) include sales and marketing expenses as well as general and administrative expenses. 4 Excludes external risks that are not yet known and/or quantifiable, including, but not limited to the effects of ongoing and/or future legal disputes and related activities, certain potential one-time effects and charges related to portfolio prioritization, as well as potential changes to the law or governmental policy, including public health policy, at the state or national level, and evolving public sentiment around vaccines and mRNA technology, in the United States and/or elsewhere. It includes effects identified from licensing arrangements, collaborations or potential M&A transactions to the extent disclosed and may be subject to update. The Company does not expect to report a positive net income figure for the 2025 financial year. Operational Review for the Fourth Quarter 2024, Key Post Period-End Events and 2025 Outlook Selected Oncology Pipeline UpdatesIn 2024, the Company’s pipeline continued to mature towards later stages of clinical development with a focus on two priority programs: our investigational next-generation immunomodulator candidate BNT327 and mRNA cancer immunotherapies. BioNTech’s oncology pipeline currently contains over 20 ongoing Phase 2 and 3 clinical trials. In 2025, the Company plans to continue progressing its pipeline towards commercialization, with its first oncology launch expected in 2026. Next-Generation Immunomodulators BNT327 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization. In December 2024, BioNTech initiated a global randomized Phase 3 clinical trial (NCT06712355) evaluating BNT327 plus chemotherapy compared to atezolizumab plus chemotherapy in first-line extensive-stage small cell lung cancer (“ES-SCLC”). In December 2024, BioNTech initiated a global randomized Phase 2/3 clinical trial (NCT06712316) evaluating BNT327 plus chemotherapy compared to pembrolizumab plus chemotherapy in first-line non-small cell lung cancer (“NSCLC”). In December 2024, at the San Antonio Breast Cancer Symposium (“SABCS”), interim data were presented from the Phase 1/2 clinical trial (NCT05918133) evaluating BNT327 in combination with chemotherapy in a cohort of patients with locally advanced, previously untreated triple-negative breast cancer (“TNBC”). In 42 patients, first-line treatment with BNT327 combined with nab-paclitaxel chemotherapy showed encouraging antitumor activity and survival outcomes regardless of PD-L1 status, together with a manageable safety profile. A global randomized Phase 3 clinical trial evaluating BNT327 in first-line TNBC is on track to start in 2025. Data from the ongoing global Phase 2 dose optimization clinical trials evaluating BNT327 in combination with chemotherapy in first-line small cell lung cancer (“SCLC”) (BNT327-01, NCT06449209) and TNBC (BNT327-02, NCT06449222) are planned to be published in 2025. Data from two Phase 2 clinical trials conducted in China in first- and second-line SCLC (NCT05844150, NCT05879068, respectively) are expected to be presented at the European Lung Cancer Congress (“ELCC”) taking place March 26-29, 2025 in Paris, France. Title: Phase 2 study of the efficacy and safety of BNT327 plus systemic chemotherapy as first-line therapy for ES-SCLCPresentation Date: March 28, 2025Poster Number: 302PAuthor: Y. Cheng Title: Updated Phase 2 efficacy and safety results of BNT327 combined with paclitaxel as second-line therapy in SCLCPresentation Date: March 28, 2025Poster Number: 332PAuthor: Y. Cheng First clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating the combination of BNT327 and BNT325/DB-1305, a TROP2-targeted antibody-drug conjugate (“ADC”) candidate, are planned to be published in 2025. Additional clinical trials exploring novel combinations of BNT327 with the ADC candidates BNT323/DB-1303 (trastuzumab pamirtecan) targeting HER2, BNT324/DB-1311 targeting B7-H3 or BNT326/YL202 targeting HER3 are planned to start in 2025. BNT316/ONC-392 (gotistobart) is an anti-CTLA-4 monoclonal antibody candidate being developed in collaboration with OncoC4, Inc. (“OncoC4”). In December 2024, the U.S. Food and Drug Administration (“FDA”) lifted the partial clinical hold on the OncoC4-sponsored Phase 3 clinical trial (PRESERVE-003; NCT05671510) evaluating the efficacy and safety of BNT316/ONC-392 as monotherapy in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. Based on the available clinical trial data and upon alignment with the FDA, the companies will solely continue enrollment of patients with squamous NSCLC. mRNA Cancer Immunotherapies Autogene cevumeran (BNT122/RO7198457) and BNT111 are investigational immunotherapies for the treatment of cancer based on BioNTech’s systemically administered uridine mRNA-lipoplex technology. Autogene cevumeran is an individualized neoantigen-specific mRNA cancer immunotherapy candidate being developed in collaboration with Genentech, Inc. (“Genentech”), a member of the Roche Group (“Roche”). In December 2024, the first patient was treated in a global randomized Phase 2 clinical trial (IMCODE004; NCT06534983) evaluating autogene cevumeran in combination with nivolumab compared to nivolumab alone as an adjuvant treatment in high-risk muscle-invasive urothelial carcinoma (“MIUC”). In January 2025, a manuscript summarizing the results of a Phase 1 clinical trial (NCT03289962) evaluating autogene cevumeran in combination with atezolizumab in patients with advanced solid tumors was published in Nature Medicine (Lopez et al., 2025). In February 2025, a manuscript denoting follow up data from an investigator-initiated Phase 1 clinical trial (NCT04161755, Rojas et al., 2023) evaluating autogene cevumeran in combination with atezolizumab in patients with pancreatic ductal adenocarcinoma (“PDAC”) in an adjuvant treatment setting was published in Nature (Sethna et al., 2025). First data from the ongoing global randomized Phase 2 clinical trial (NCT04486378) evaluating autogene cevumeran as an adjuvant treatment compared to watchful waiting after standard of care chemotherapy in resected circulating tumor DNA+ (“ctDNA”) stage II (high-risk) and III colorectal cancer (“CRC”) are anticipated in late 2025 or early 2026. BNT111 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and encodes four melanoma-associated antigens. BioNTech plans to present data from the ongoing Phase 2 clinical trial (BNT111-01; NCT04526899) at a medical conference in 2025. In 2024, an initial topline readout was provided noting that the clinical trial had met its primary efficacy outcome measure, demonstrating a statistically significant improvement in overall response rate (“ORR”) in patients with anti-PD-(L)1 refractory/relapsed, unresectable stage III or IV melanoma treated with BNT111 in combination with cemiplimab as compared to historical control in this treatment setting. Antibody-Drug Conjugates BNT323/DB-1303 (trastuzumab pamirtecan) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”). BNT323/DB-1303 is being evaluated in a Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent or metastatic HER2-expressing solid tumors. Data from patients with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) advanced endometrial carcinoma are expected in 2025. A confirmatory Phase 3 clinical trial (NCT06340568) is planned to start in 2025. Preparation of a potential Biologics License Application (“BLA”) submission for BNT323/DB-1303 as a second line or subsequent therapy in HER2-expressing advanced endometrial cancer in 2025. BNT324/DB-1311 is an ADC candidate targeting B7-H3 that is being developed in collaboration with DualityBio. The program has received Fast Track designation from the FDA for the treatment of patients with advanced castration-resistant prostate cancer (“CRPC”) who have progressed on or after standard systemic regimens and Orphan Drug designation for the treatment of patients with advanced esophageal squamous cell carcinoma. In December 2024, preliminary data from the first-in-human, open-label Phase 1/2 clinical trial (NCT05914116) were presented at the 2024 European Society for Medical Oncology (“ESMO”) Asia Congress, demonstrating encouraging efficacy and a manageable safety profile across a range of advanced solid tumors. Cell Therapies BNT211 consists of a CAR-T cell product candidate targeting CLDN6-positive solid tumors in combination with a CAR-T cell-amplifying RNA cancer immunotherapy encoding CLDN6. In January 2025, the FDA granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for BNT211. The RMAT designation is designed to expedite the development and review process for promising pipeline products, including cell therapies. A pivotal Phase 2 clinical trial in patients with testicular germ cell tumors is expected to start in 2025 based on encouraging clinical activity observed in this patient population in the ongoing Phase 1 clinical trial (NCT04503278). The Phase 1 clinical trial is ongoing to evaluate BNT211 in other CLDN6+ cancer types, including NSCLC and gynecologic cancers. Selected Infectious Diseases Pipeline Updates BioNTech and Pfizer developed, manufactured and delivered JN.1- and KP.2-adapted COVID-19 vaccines which received multiple regulatory approvals and marketing authorizations in more than 40 countries and regions. In 2024, BioNTech and Pfizer delivered approximately 180 million variant-adapted COVID-19 vaccine doses worldwide. BioNTech and Pfizer continue to invest in the research and development of next-generation and combination COVID-19 vaccine candidates. Corporate Update for the Fourth Quarter 2024 and Key Post Period-End Events In November 2024, BioNTech signed an agreement to acquire Biotheus and obtain full global rights to BNT327 and to all other candidates from Biotheus’ pipeline, as well as to its in-house antibody generation platform and bispecific ADC capability. The transaction amounted to an upfront consideration of $800 million, plus additional performance-based payments of up to $150 million. The acquisition was completed in February 2025. Upcoming Investor and Analyst Events Sustainability Report 2024 Publication: March 24, 2025 Annual General Meeting: May 16, 2025 Innovation Series AI Day: October 1, 2025 Innovation Series R&D Day: November 18, 2025 Conference Call and Webcast InformationBioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, March 10, 2025, at 8:00 a.m. EDT (1:00 p.m. CET) to report its financial results and provide a corporate update for the fourth quarter and full year 2024. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN number will be provided. The slide presentation and audio of the webcast will be available via this link. Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor section of the Company’s website at www.BioNTech.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call. About BioNTechBiopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit www.BioNTech.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s expected revenues and net profit/(loss) related to sales of BioNTech’s COVID-19 vaccine, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, in territories controlled by BioNTech’s collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech’s partners; the rate and degree of market acceptance of BioNTech’s COVID-19 vaccine and, if approved, BioNTech’s investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs, including BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or clinical trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech’s expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational clinical trials, and the registrational potential of any clinical trial BioNTech may initiate; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements; the development, nature and feasibility of sustainable vaccine production and supply solutions; the deployment of AI across BioNTech’s preclinical and clinical operations; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; BioNTech’s expectations regarding upcoming payments relating to litigation settlements; BioNTech’s expectations for upcoming scientific and investor presentations; and BioNTech’s expectations of net profit/(loss). In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech’s pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 20-F for the period ended December 31, 2024 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. CONTACTS Investor RelationsMichael HorowiczInvestors@biontech.de Media Relations Jasmina Alatovic Media@biontech.de Target abbreviation directory Consolidated Statements of Profit or Loss Consolidated Statements of Financial Position Consolidated Statements of Cash Flows 1 All target abbreviations are compiled in an abbreviation directory at the end of this press release.** All numbers in this press release have been rounded.

Phase 2Phase 1Clinical ResultImmunotherapyVaccine

06 Mar 2025

·endpts.com

No news is good news? Merck KGaA quiet on potential SpringWorks takeover

Ahead of Merck KGaA’s earnings announcement Thursday, investors were mostly looking forward to any comments about its potential buyout of SpringWorks Therapeutics. But the German pharma was tight-lipped. “There is very little that we can say at this time,” CEO Belén Garijo said during a call with the media Thursday. Last month, Merck KGaA confirmed reports that it is in active discussions to buy the cancer biotech. Soon after, the Stamford, CT-based biotech canceled its full-year earnings call. And the deal hasn’t come through yet. SpringWorks’ share price $SWTX initially crept up premarket Thursday by around 5% but is now down 4%. Speaking generally on M&A, Garijo said its “top priority remains to action our life science M&A [strategy], either on the basis of bolt-on acquisitions as we have done to date or … other options.” The company has already been executing on this front: It expanded its viral manufacturing capacity with a $600 million buyout of Mirus Bio in May 2024 and is eyeing more manufacturing deals . Media reports of the potential SpringWorks acquisition began circulating on Feb. 10, prompting Merck KGaA to issue an ad hoc release within hours confirming “advanced discussions” with SpringWorks. At the time, the company said that “critical conditions have yet to be met.” If the deal goes through, the German drugmaker would obtain SpringWorks’ desmoid tumor medicine Ogsiveo, its benign nerve tumor treatment Gomekli and a pipeline of cancer candidates. Oncology has become a key focus area for Merck KGaA in recent years. At the JP Morgan Healthcare Conference in January, Merck KGaA’s healthcare CEO Peter Guenter said it has already built a “stronghold” in solid tumors with Erbitux for colorectal cancer and Bavencio for bladder cancer. “We will continue to invest not only in the pipeline, but also looking actively at possible in-licensing deals,” he added, according to an AlphaSense transcript. The company’s top-selling medicine is Erbitux, which reached €1.16 billion ($1.25 billion) in 2024 sales, according to its annual report . Overall sales of Merck KGaA’s cancer franchise increased 24% from 2023 to more than €2 billion ($2.2 billion) last year.

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100 Deals associated with Cetuximab

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KEGG	Wiki	ATC	Drug Bank
D03455	Cetuximab	L01XC06	DB00002

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Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
RAS Wild Type Colorectal Cancer	Australia	Merck Healthcare Pty Ltd.	25 Sep 2007
Head and Neck Neoplasms	United States	Eli Lilly & Co.	01 Mar 2006
Metastatic Colorectal Carcinoma	European Union	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	Iceland	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	Liechtenstein	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	Norway	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	European Union	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	Iceland	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	Liechtenstein	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	Norway	Merck Europe BV	29 Jun 2004
Colorectal Cancer	Switzerland	Merck & Co., Inc.	01 Dec 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
KRAS G12C mutant Colorectal Cancer	Phase 3	United States	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	China	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	Argentina	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	Australia	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	Austria	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	Belgium	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	Brazil	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	Canada	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	Colombia	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	Czechia	Mirati Therapeutics, Inc.	24 Jun 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03785249 (KRYSTAL-1, ASCO_GI2025) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer Second line KRAS G12C	94	Adagrasib + Cetuximab	hyzzaosmma(prbvqjxlad) = pahxjofqne sxyxesysmv (bufcgqbjka, 32 - 53) View more	Positive	23 Jan 2025
NCT04607421 (BREAKWATER, ASCO_GI2025 \| Pubmed \| FDA) Manual	Phase 3	BRAF V600E mutant Colorectal Cancer First line BRAF V600E	479	Encorafenib + Cetuximab + FOLFOX	xwsykkygwn(yiteaoiwaz) = dsexthbfss oghcybrzcu (razwrxbdeb, 51.6 - 69.5) View more	Positive	23 Jan 2025
				Standard of Care (chemo with or without bevacizumab)	xwsykkygwn(yiteaoiwaz) = zvvvdfmssr oghcybrzcu (razwrxbdeb, 31.3 - 49.3) View more
JPRN-jRCTs061180022 \| NCT02515734 (JACCRO CC-13, ASCO_GI2025) Manual	Phase 2	RAS Wild Type Colorectal Cancer RAS wild-type	359	m-FOLFOXIRI plus cetuximab	zogwgafjxh(bpmbeaifom) = pzqvvbbnou ozkjsdvher (jpjlllrctc ) View more	Positive	23 Jan 2025
				m-FOLFOXIRI plus bevacizumab	zogwgafjxh(bpmbeaifom) = sscwozzrzy ozkjsdvher (jpjlllrctc ) View more
NEW BEACON (ASCO_GI2025)	Phase 2	BRAF V600E mutant Colorectal Cancer BRAF V600E mutated	20	Cetuximab every second week + Encorafenib	vyywwbhudi(babxcahvqu) = ycucxmhphy ckdzavjhbq (yljaedxdlv )	Positive	23 Jan 2025
NCT04241731 (ESMO_ASIA2024) Manual	Phase 2	RAS Wild Type Colorectal Cancer Maintenance \| First line RAS wild-type	31	Cetuximab plus Raltitrexed	gawhpplbfq(wrehkqxtsu) = ltccwdpywc lgvfqcahpo (zfcxrqzoet, 3.2 - 12.0) View more	Positive	07 Dec 2024
NCT03258554 (NRG-HN004, Pubmed \| Lancet Oncol) Manual	Phase 2/3	Head and Neck Neoplasms	186	Durvalumab	uokdfvmuwq(lrwauahzyj) = The most common grade 3-4 adverse events were dysphagia (26 [22%] of 119 patients in the durvalumab group vs 18 [30%] of 61 patients in the cetuximab group), lymphopenia (33 [28%] vs 20 [33%]), and oral mucositis (13 [11%] vs 11 [18%]). fnualflqen (qfeqnpvzmw ) View more	Negative	01 Dec 2024
				Cetuximab
SITC2024 Manual	Phase 1	Colorectal Cancer Proficient DNA Mismatch Repair (pMMR)	15	pre-A+E CBNK cells + cetuximab	hlcevweibl(vjyvcnbnkm) = None lpdecgsewk (vzhcwcnsac ) View more	Positive	05 Nov 2024
NCT04717375 (623, SITC2024)	Phase 1	Solid tumor	76	SAR444881 monotherapy	xnimlfwzza(ahbccnldko) = 19% ryvbqlirff (cvpwfvevcj ) View more	Positive	05 Nov 2024
				SAR444881 + pembrolizumab
NCT04117945 (CTgov)	Phase 2	Adenocarcinoma of large intestine \| Colorectal Cancer, Hereditary Nonpolyposis, Type 1 \| Metastatic Colorectal Carcinoma	22	Regorafenib (Arm A (Regorafenib))	tcofshikwb(amsryubhzf) = finmdhoxkv lesbklommr (txoynvykzj, jmueauhjkn - nlrhmdjoew) View more	-	27 Sep 2024
				Cetuximab+Irinotecan+Panitumumab (Arm B (Cetuximab, Panitumumab, Irinotecan))	tcofshikwb(amsryubhzf) = ftqggcfjel lesbklommr (txoynvykzj, kmrrnruifl - yyplqmeixn) View more
NCT04262635 (C-CLASSIC, ESMO2024) Manual	Phase 3	RAS/BRAF Wild Type Colorectal Cancer Maintenance RAS/BRAF wild type	80	Cetuximab + Capecitabine	fsvrfmsubp(isbochrqhe) = sfpynljscs oqevqxvbju (yrllrnkzyu, 5.32 - 11.24) View more	Positive	16 Sep 2024
				Cetuximab	fsvrfmsubp(isbochrqhe) = yvcngufnzr oqevqxvbju (yrllrnkzyu, 3.02 - 7.46) View more

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