AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments.
To join in the study, participants must:
* Be 18 years or older
* Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread
The study will look at:
* Whether PF-08634404 is safe to use with other cancer medicines.
* What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.
* Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors.
The study has different parts, each testing PF-08634404 with a different cancer medicine:
* Part A will test PF-08634404 with a medicine called sigvotatug vedotin.
* Part B of the study will look at how well the new medicine PF-08634404 works when used together with another medicine.
Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.

Start Date30 Jan 2026

Sponsor / Collaborator

Pfizer Inc.

NCT06758401

/ RecruitingPhase 3

AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)

The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of "brake" to keep the body's immune responses under control.
The study is seeking for participants who:
* Are confirmed to have NSCLC (Stage 3 or 4).
* Have PD-L1 levels in more than 50% of the cancer cells.
All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab.
Participants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.

Start Date23 Jul 2025

Sponsor / Collaborator

Pfizer Inc.

NCT06549816

/ CompletedPhase 1

An Open-label, Phase 1 Study to Investigate the Safety and Pharmacokinetics of SGN-B6A in Chinese Subjects With Advanced Solid Tumors

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) to find out whether it is safe for Chinese participants who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how do Chinese participants' body interact with sigvotatug vedotin.

Start Date21 Aug 2024

Sponsor / Collaborator

Seagen, Inc.

100 Clinical Results associated with Sigvotatug vedotin

100 Translational Medicine associated with Sigvotatug vedotin

100 Patents (Medical) associated with Sigvotatug vedotin

417

Literatures (Medical) associated with Sigvotatug vedotin

20 Dec 2025·Future Oncology

Frontline sigvotatug vedotin plus pembrolizumab vs pembrolizumab for non-small cell lung cancer with PD-L1 tumor proportion score ≥50%: phase III study design

Article

Author: Tay, Fabian ; Negrao, Marcelo V. ; Reck, Martin ; Pavlov, Dmitri ; Lu, Shun ; Barrios, Carlos ; O’Byrne, Kenneth J.

Integrin beta-6 (IB6) is a tumor-associated membrane protein involved in many cellular processes, including wound healing and tissue remodeling. While IB6 expression is constitutively low in healthy tissues, high IB6 expression in numerous cancers, including non-small cell lung cancer (NSCLC), is associated with poor outcomes. In a phase I study, the novel IB6-directed vedotin-based antibody-drug conjugate sigvotatug vedotin (SV) showed manageable safety and encouraging efficacy as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, including NSCLC. Based on those results, the phase III Sigvie-003 study is evaluating SV plus pembrolizumab compared with pembrolizumab monotherapy as first-line treatment in adult patients with locally advanced, unresectable, or metastatic NSCLC with high programmed cell death ligand 1 expression (tumor proportion score ≥50%). Here, we describe the design of the Sigvie-003 study, which is an open-label, randomized, controlled phase III study. Approximately 714 patients will be randomized 1:1. The dual primary endpoints are progression-free survival as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors v1.1 and overall survival; secondary endpoints include additional efficacy, safety and tolerability, pharmacokinetics, and immunogenicity endpoints.Clinical trial registration: NCT06758401 (https://clinicaltrials.gov/study/NCT06758401).

12 Jun 2025·ACS Medicinal Chemistry Letters

Site-Selective Anti-PD-L1 Antibody–MMAE Conjugate for Enhanced NSCLC Therapy

Article

Author: Kwon, Se Jeong ; Son, Jinyoung ; Chung, Sang J.

Nonsmall cell lung cancer (NSCLC) presents significant therapeutic challenges, causing advancements in targeted therapies. We have developed a site-selective antibody-drug conjugate (ADC), durvalumab-monomethyl auristatin E (MMAE), with a drug-antibody ratio (DAR) of 4, specifically targeting programmed death-ligand 1 (PD-L1), aimed at enhancing NSCLC therapy. Utilizing the innovative AbClick Pro linker, this ADC ensures stable, site-specific conjugation of MMAE to durvalumab, preserving antibody functionality and integrity. In vivo studies demonstrate that durvalumab-MMAE achieves substantial tumor growth inhibition in NSCLC xenograft models, with an impressive tumor growth inhibition rate of over 60% at lower dosages without significant toxicity. These results, combined with a favorable pharmacokinetic profile featuring extended half-life and low clearance, highlight the potential of durvalumab-MMAE (DAR4) as a potent next-generation ADC for treating PD-L1-expressing cancers, offering a promising avenue for improved NSCLC patient outcomes.

01 Jun 2025·Pharmaceutical Fronts

Design, Development, and Antitumor Potential of CD228-Targeted Antibody–Drug Conjugates

Author: Xie, Liping ; Qiu, Haitao

Abstract:

Melanotransferrin (CD228) is a membrane glycoprotein involved in tumor growth and metastasis and is highly expressed in various solid tumors. Despite its tumor-specific nature, no antibody drugs targeting CD228 are currently available. This study aimed to develop a humanized CD228 monoclonal antibody and its antibody–drug conjugate (ADC) to evaluate in vitro cytotoxicity and in vivo antitumor efficacy against melanoma. In this work, mice were immunized with the extracellular domain of CD228, and specific antibodies were screened using hybridoma technology, followed by humanization. The humanized antibody was conjugated to monomethyl auristatin E (MMAE) with a citrulline–valine linker and purified by protein A chromatography. The drug–antibody ratio (DAR) and purity were analyzed using hydrophobic interaction chromatography and size-exclusion chromatography. CCK8 assay was performed to assess cytotoxicity against tumor cells, and antibody-dependent cell-mediated cytotoxicity (ADCC) was assessed using Jurkat cells. An A2058 melanoma xenograft model was used to examine in vivo efficacy. This work identified a humanized antibody, Ab-2F6A1, with high CD228 binding affinity, with EC50 values of 1.746 ng/mL (protein binding activity) and 83.8 ng/mL (cell binding activity). The ADC, Ab-2F6A1-VcMMAE, had an average DAR of 4.9026 and a purity of 98.24% and showed significant in vitro cytotoxicity against melanoma, breast, and colon cancer cells. Ab-2F6A1-VcMMAE has a stronger ADCC effect compared with the positive control (Ab-hI49-VcMMAE), and exhibited superior melanoma tumor inhibition in vivo. Given the above, a novel humanized anti-CD228 antibody and its ADC were successfully developed. The ADC demonstrated strong antigen binding, in vitro antitumor activity, ADCC effects, and superior in vivo melanoma inhibition, supporting CD228 as a promising therapeutic target.

News (Medical) associated with Sigvotatug vedotin

04 Mar 2026

·www.fiercebiotech.com

Pfizer\'s oncology R&D strategy: Jeff Legos on speed, breadth and novel combinations

Pfizer’s urgency to quickly expand the clinical program of its PD-1xVEGF bispecific antibody highlights a thrilling race to develop a successor to displace Keytruda, the current immuno-oncology king.\n Oncology projects currently take up about 40% of Pfizer’s overall R&D budget. Behind this construction is Jeff Legos, Ph.D., who became the firm’s chief oncology officer last year following a high-profile move from Novartis.After steering positive key pivotal readouts for a trio of Novartis’ blockbusters—Kisqali, Pluvicto and Scemblix—Legos is now tasked with fleshing out Pfizer’s $43 billion Seagen acquisition into an antibody-drug conjugate empire while accelerating a PD-1xVEGF bispecific licensed from 3SBio toward 2028 readouts.For the closely watched PD-1xVEGF competition, Legos’ strategy for Pfizer is anchored by three pillars: speed, breadth and novel combinations.“We are operating under very expedited timelines in terms of the first wave of studies,” Legos said in an interview with Fierce Biotech. Slamming the gasPfizer cleared regulatory requirements and completed the licensing agreement for 3SBio\'s PD-1xVEGF bispecific toward the end of July 2025. For an upfront payment of $1.25 billion and potential milestones of up to $4.8 billion, Pfizer gained ex-China rights to SSGJ-707, now also known as PF-08634404.By the end of 2025, Pfizer would have had regulatory discussions with the FDA and launched seven clinical trials, including three phase 3 studies, for the PD-1xVEGF drug. And the company plans to start another five studies by June this year. Normally, it would take about a year from clinical ideation to a study start, Legos noted.As to breadth, Pfizer is examining all of the existing indications of Merck & Co.’s Keytruda, trying to figure out where the PD-1xVEGF inhibitor can go, with additional considerations paid to disease prevalence and unmet medical need, Legos said. The urgency to quickly expand PF-08634404’s clinical program highlights a thrilling race to develop a successor to displace Keytruda, the current immuno-oncology king. To justify its price tag, Pfizer has talked about how PF-08634404 is differentiated from other candidates from a chemistry and biological mechanism perspective. But the phase 3 programs that Pfizer has outlined so far appear similar—if not identical—to what its rivals Summit Therapeutics/Akeso and BioNTech/Bristol Myers Squibb are undertaking for their PD(L)1xVEGF candidates.Some of the same settings where Pfizer is running phase 3 include a first-line non-small cell lung cancer study pitting PF-08634404 against Keytruda in their respective combinations with chemotherapy across both squamous and nonsquamous histologies, against Roche’s Tecentriq and chemo in first-line extensive-stage small cell lung cancer, and phase 3 tests in first-line gastric cancer and first-line colorectal cancer. PF-08634404 is a tetravalent antibody with four binding domains, two each for PD-1 and VEGF. The structure provides more robust cooperative binding and create a so-called “daisy chain” effect that could bring more cancer-killing T cells to the tumor microenvironment, Legos explained.“Despite that [scientific rationale], it does come down to clinical data, and that’s why we are required to test it in these very well-defined patient populations,” Legos said.Even though Keytruda has established itself as the standard of care in first-line NSCLC, only about 30% of patients benefit from immunotherapy, and only 30% of those patients benefitting experience long-term, durable responses, Legos observed. And in colorectal cancer, immunotherapy remains less effective in microsatellite-stable tumors. The unmet need prompted Pfizer to study whether PF-08634404 can improve patients’ outcomes, he said. Can PD-1xVEGF live up to its promise?Despite billions of dollars being poured into the PD-(L)1xVEGF space, the main criticism against the class is its seemingly weak ability to turn slowing tumor progression into prolonging patients’ lives. Summit and Akeso’s first-in-class ivonescimab recently showed a 26% death risk reduction in Chinese patients with previously treated EGFR-mutated NSCLC at the final analysis of the phase 3 HARMONi-A trial. But when it comes to the global HARMONi trial, the overall survival data failed to meet statistical significance.Legos argues that those data shouldn’t discount the broader potential of the PD-1xVEGF mechanism. Neither PD-1 nor VEGF inhibitor works very well separately in EGFR-mutated NSCLC, so it’s “not so surprising that the overall survival data is more borderline,” he said.And the problem may not be PD-1xVEGF anyway.“When you design a study with smaller patient numbers, in order to meet predefined endpoint around progression-free survival, you may not have enough power to sufficiently demonstrate the overall survival benefit,” Legos said.For PF-08634404, Pfizer plans to make overall survival at least a primary endpoint in all its phase 3 trials.“It comes down to the intention of the trial and your statistical analysis plan up front, and then ultimately the patient population that we are studying,” he said. Answers to the question of whether Pfizer’s PD-1xVEGF drug can be the next Keytruda will start to emerge in 2028, when the company expects readouts from the first wave of its phase 3 programs.However, the landscape of cancer care is forever evolving, and PD-(L)1xVEGF is not the only force that has its eyes on the prize. Notably, Merck is investing aggressively in its Kelun Biotech-partnered TROP2 antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) but has been quiet on its own PD-1xVEGF bispecific after licensing the asset from China’s LaNova Medicines—now part of Sino Biopharm—in late 2024.“I’m not sure it’s an either-or, because they’re doing two very different things,” Legos said of a potential showdown between PD-1xVEGF bispecifics and TROP2 ADCs.ADCs, as targeted missiles to deliver a cancer-killing payload, can achieve immediate cytotoxic cell death.“But frankly, we’re not just looking for improvements in response rates,” Legos continued. “Without engaging the immune system, I think the benefit of just a single modality may be limited in terms of its fullest potential.”Merck is already pairing sac-TMT with Keytruda in phase 3 trials in multiple tumor settings. As to whether a TROP2 ADC can be combined with a PD-1xVEGF bispecific, “those experiments would have to be done,” Legos said. Expanding Pfizer’s oncology pipelineCombination with other novel agents, including ADCs, is already on Legos’ agenda, forming the third pillar of his strategy in hopes of truly differentiating PF-08634404 from its peers. One of the phase 3 studies being planned pairs PF-08634404 with Pfizer’s Astellas-partnered ADC Padcev in first-line bladder cancer, a setting where the Padcev-Keytruda combo has recorded standing ovation-worthy data. Following the Seagen buy, questions persist regarding Pfizer’s ability to build a sustainable ADC pipeline while avoiding the path of Gilead Sciences, which has not produced a new ADC beyond the TROP2-directed Trodelvy in the six years since its $21 billion acquisition of Immunomedics. Pfizer discontinued a B7-H4 ADC a year ago and has repeatedly pared back efforts around its RemeGen-partnered HER2 ADC disitamab vedotin.Legos remains optimistic that new ADCs are coming out of Pfizer. Among eight key readouts that Pfizer expects this year across the group, sigvotatug vedotin, an ADC targeting integrin-beta6, is expected to report phase 3 data in second-line nonsquamous NSCLC in the first half of 2026.With its biology experts and partners, Pfizer is profiling novel antigens to target for next-generation ADCs and is examining “a variety of permutations,” such as bispecific antibody constructions and novel payloads, Legos said.“Instead of just focusing on traditional cytotoxic payloads, which I think have done very well, we’re now leveraging our small-molecule chemistry, and these could be low molecular weight inhibitors, they could be molecular glues, they could be targeted protein degraders,” Legos said. “These can become the basis of payloads where you can deliver very high dose, high concentration of a specific inhibitor directly to the cancer cells, thereby minimizing any safety or tolerability challenges but optimizing a therapeutic index.”The mix-and-match has already begun. Instead of the vedotin payload, Pfizer is testing another integrin beta6 candidate with a TOPO1 payload in phase 1 dose escalation, and is developing a third intravesical molecule with a unique payload in non-muscle invasive bladder cancer to complement Padcev, according to Legos.“We are working on modifying all of those different variables to bring forward what we believe to be a potentially practice-changing ADC in our priority disease areas,” Legos said. The Pfizer oncology pipeline currently includes traditional small molecules, regular antibodies, ADCs and bispecifics, including T-cell engager. But the company does not have any CAR-T projects. Pfizer Ventures was a top investor in Capstan Therapeutics, an in vivo CAR-T biotech that was recently bought by AbbVie. Legos said he’s “fairly agnostic to” modalities and is “completely open […] to pursue innovation wherever it originates.”“We have all of the building blocks that hopefully helps us accelerate the time to patient, but we are open and interested to explore all types of innovation, irrespective of modality,” he said.While the large deals for Seagen and 3SBio’s PD-1xVEGF drug have put rejuvenation of oncology at the top of Pfizer investors’ mind, obesity has grabbed their attention lately in the forms of Pfizer’s $10 billion takeover of Metsera and a $1.9 billion biobucks deal for new GLP-1 therapies from Fosun Pharma.Pointing to oncology’s 40% allocation of Pfizer’s entire R&D budget, Legos said he’s not worried about competition for resources internally with metabolic diseases but sees potential for mutual lessons sharing.“I’m very hopeful about the potential intersections of cancer and the insulin axis as it relates to the future of care,” Legos said. “For a company that actually can be a leader in obesity and in oncology, it’s an opportunity to think about how cancer care is done on the backbone of GLP-1, amylin, GIP as part of the future.”

$Pfizer\'s oncology R&D strategy: Jeff Legos on speed, breadth and novel combinations$

Phase 3ImmunotherapyLicense out/inAcquisitionPhase 1

12 Sep 2025

·endpoints.news

Pfizer has a VEGF bispecific strategy. And it’s very different than Summit’s

As Wall Street continues to digest this week’s disappointing results for Summit Therapeutics’ PD-1xVEGF bispecific cancer drug, one competitor is primed to take advantage. Summit’s stock $SMMT closed 20% lower on Monday after the company shared full data showing its drug ivonescimab might be less efficacious in Western patients than those in China. It’s the first time that executives there have had to play defense , and some observers — including the most bearish sell-side Summit analyst — are questioning whether bispecifics work if not combined with other therapies. “We have increased conviction that the bispecifics are best placed as backbones for novel/novel combinations and/or in settings where they can replace [Avastin] standard of care,” Leerink’s Daina Graybosch wrote in a Tuesday note to investors. Enter Pfizer. As recently as this spring, the drugmaker wasn’t the obvious choice. It only entered the VEGF bispecific race in May, when it signed a licensing deal with Shenyang, China-based 3SBio for the rights to SSGJ-707. The drug still hadn’t entered a Phase 3 study in China when the companies signed the deal, though Pfizer now describes a global Phase 3 as a “ priority .” But Pfizer isn’t planning to conduct any trials pitting SSGJ-707 directly against standard of care or placebo at this time. Instead, it will run studies that combine the drug with the antibody-drug conjugates it acquired from Seagen, Pfizer’s head of thoracic oncology Arati Rao told Endpoints News in a recent interview. “For us to do a study like the Summit study, as a global study, would be tough,” Rao said last month. “We have this great advantage at Pfizer of having this wealth of multiple ADCs that we can combine with, or work with, that we don’t want to muddy those waters.” Rao said Pfizer could change course and still run a monotherapy trial for SSGJ-707, on which she has oversight. Rao and Jeff Legos, Pfizer’s chief oncology officer, have said SSGJ-707 has the potential to be more efficacious than PD-1 checkpoint inhibitors alone on a call with investors in July. They describe it as “structurally distinct” from other PD-1xVEGF programs. In lung cancer, however, Rao said the space is “pretty crowded right now,” including Pfizer’s other ADC trials. She pointed to a Phase 3 study in lung cancer for sigvotatug vedotin as a reason against launching a similar trial for SSGJ-707. Sigvotatug vedotin comes from Pfizer’s roughly $43 billion acquisition of Seagen in 2023. If Pfizer wanted to do a monotherapy trial in lung cancer, it would have to enroll only patients with at least 50% expression of PD-1 or PD-L1 on their tumor cells to beat the standard of care, Rao added. “The bottom line is we don’t need to have a monotherapy study,” Rao said. “Our time is better spent treating patients who truly need this drug in combination with chemo or with something else.” It’s possible other companies will soon start combining their PD-1xVEGF bispecifics as well. Pumitamig, which is at the heart of a licensing deal between Bristol Myers Squibb and BioNTech, is a program ripe for combination, according to Graybosch. She also expects Merck to take a similar approach with the bispecific program it licensed from LaNova Medicines, though that drug is in an earlier stage of development compared to pumitamig. At the end of the day, it’s Merck that every company is chasing: The PD-1xVEGF bispecific class is the biggest threat to its immunotherapy Keytruda, the world’s top-selling drug.

License out/inPhase 3AcquisitionADCImmunotherapy

23 Apr 2025

·www.businesswire.com

Pfizer Advances Bold Vision for Future of Cancer Care at the ASCO 2025 Annual Meeting

ASCO press program to feature overall survival and progression-free survival data for BRAFTOVI ® (encorafenib) combination regimen in first-line BRAF V600E -mutant metastatic colorectal cancer and progression-free survival data from VERITAC-2 study of vepdegestrant in metastatic breast cancer NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) will showcase data across its portfolio of potential breakthrough cancer medicines at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 30 to June 3 in Chicago. Data from more than 60 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 9 oral presentations and 6 rapid oral presentations, will be presented across Pfizer’s key tumor areas, including breast, genitourinary, hematologic, and thoracic cancers, as well as colorectal cancer. “This has already been a significant year for Pfizer’s Oncology pipeline, with multiple Phase 3 data readouts and regulatory approvals, and the initiation of pivotal registrational programs across our major tumor areas of focus,” said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research & Development, Pfizer. “The depth and diversity of our data presentations at ASCO are building on that momentum to bring us closer to our goal of delivering eight breakthrough cancer medicines by 2030.” Pfizer will have two late-breaking oral presentations featured in ASCO’s embargoed pre-meeting press briefing on May 27. These include the primary analysis of the pivotal overall survival (OS) and progression-free survival (PFS) results from the Phase 3 BREAKWATER study investigating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer,* as well as the first presentation of the PFS results from the Phase 3 VERITAC-2 study of vepdegestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (a/mBC) in partnership with Arvinas.** Pfizer will share additional updates from key late-stage programs, including five-year survival data from the Phase 3 ARCHES study of XTANDI® (enzalutamide) in combination with androgen deprivation therapy in metastatic hormone-sensitive prostate cancer (mHPSC),*** and the first combination data for ELREXFIO® (elranatamab) + daratumumab + lenalidomide from the ongoing MagnetisMM-6 study in patients with transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM). Pfizer will also share new findings highlighting the company’s strategy to explore novel vedotin antibody-drug conjugates (ADCs) in combination with immune checkpoint inhibitors to potentially enhance anti-tumor activity. For the first time, Pfizer will present encouraging Phase 1 data on two novel investigational ADCs in combination with pembrolizumab in thoracic cancers: sigvotatug vedotin (SV), an integrin beta-6 (IB6)-directed ADC, in lung cancer and head and neck cancers, and PDL1V (PF-08046054), a PD-L1 directed ADC, in head and neck cancers. Additionally, new exploratory analyses will be presented from the pivotal EV-302 trial with PADCEV® (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).**** Several presentations will highlight updated results from ongoing Phase 1 studies that inform the dosing strategy in registrational programs for two molecules targeting epigenetic regulators: mevrometostat, an investigational EZH2 inhibitor being evaluated in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC); and PF-07248144, a potential first-in-class KAT6 inhibitor for ER+/HER2- metastatic breast cancer (mBC). “Our data at ASCO this year reflect how we are strategically progressing our deep pipeline of next generation cancer medicines while simultaneously extending the impact of our foundational therapies to reach more people living with cancer,” said Megan O’Meara, Head of Early-Stage Development and Interim Head of Late-Stage Development, Pfizer Oncology. “Important early-stage updates highlight our extensive pipeline and depth within our core cancer types, as we advance up to nine new pivotal Phase 3 trials this year.” Key ASCO Presentations Colorectal Cancers BRAFTOVI : A late-breaking session will detail PFS and OS results from the Phase 3 BREAKWATER study of BRAFTOVI in combination with cetuximab and mFOLFOX6 chemotherapy in BRAF V600E -mutant metastatic colorectal cancer, further establishing the benefit of the BRAFTOVI combination regimen following its FDA accelerated approval in late 2024. These pivotal study results follow the topline results announcement for PFS and OS and the objective response rate (ORR) results presented at ASCO GI . These new data will also be featured in the ASCO press program. Breast Cancer Vepdegestrant : In a late-breaking session, PFS data will be presented for the first time from the Phase 3 VERITAC-2 study of vepdegestrant, a PROTAC ER degrader, in ER+/HER2− a/mBC. These detailed data follow the topline results from VERITAC-2 announced earlier this year and will also be featured in the ASCO press program. PF-07248144 (KAT6 inhibitor) : A rapid oral presentation will highlight dose optimization data from an ongoing Phase 1 study for PF-07248144, a potential first-in-class KAT6 inhibitor, in patients with ER+/HER2− mBC. These results support the recommended dosing for PF-07248144 ahead of the Phase 3 trial initiation in second-line mBC planned for 2H 2025. IBRANCE ® (palbociclib) : Roche will present detailed results from the OS analysis of the Phase 3 INAVO120 study investigating ITOVEBI™ (inavolisib) in combination with IBRANCE and fulvestrant in patients with PIK3CA -mutated, HR+/HER2-, endocrine-resistant, locally a/mBC. This presentation will be featured in ASCO’s embargoed pre-meeting press briefing on May 21. Genitourinary Cancers XTANDI : Five-year follow-up overall survival data from the ARCHES study of XTANDI in combination with androgen deprivation therapy in patients with mHSPC will be featured in an oral presentation. In addition, updates from the Astellas-supported, investigator-sponsored ENZAMET Phase 3 research study, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and sponsored by the University of Sydney, will also be presented, including 8 year-outcomes in men with mHSPC. These presentations further underscore the value of XTANDI across approved indications. Mevrometostat : A poster presentation will highlight pharmacokinetic and safety data from the ongoing Phase 1 study for mevrometostat, an investigational EZH2 inhibitor, in combination with XTANDI. These updated data further inform the dosing strategy for mevrometostat in a robust registrational program that includes two Phase 3 trials in mCRPC, and a third trial in metastatic castration-sensitive prostate cancer (mCSPC) that is planned to start in 1H 2025. PADCEV : Additional updates from the Phase 3 EV-302 study of PADCEV in combination with KEYTRUDA in previously untreated la/mUC will be presented, including an oral presentation with exploratory analysis of responders. Hematologic Cancers ELREXFIO : Initial safety and efficacy results from Part 1 of the ongoing MagnetisMM-6 study of ELREXFIO in combination with daratumumab and lenalidomide in patients with newly diagnosed MM that are not eligible for transplant will be presented as an oral presentation. Part 1 of the ongoing MagnetisMM-6 study evaluates the optimal dose of the ELREXFIO combination regimen in patients with RRMM or NDMM to determine the recommended phase 3 dose for part 2. Thoracic Cancers Sigvotatug vedotin (SV): Phase 1 results for SV, an IB6-directed vedotin ADC, in combination with pembrolizumab in non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) will be featured in a rapid oral presentation. This initial combination data for SV with pembrolizumab support a Phase 3 study in first line PD-L1-High NSCLC, initiated this year. The data also support the overall SV trial program that includes an ongoing Phase 3 monotherapy trial in second line+ NSCLC. PDL1V (PF-08046054) : Two poster presentations will highlight interim Phase 1 results for PDL1V, a PD-L1 directed vedotin ADC, as monotherapy in NSCLC and initial safety and efficacy data in combination with pembrolizumab in patients with first-line recurrent or metastatic (r/m) HNSCC. These data provide additional support for the initiation of the two pivotal Phase 3 trials planned for PDL1V in 2025 in second line+ NSCLC and first line r/mHNSCC. Additional information on key Pfizer-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting May 22, 2025. COLORECTAL CANCERS Oral Presentation (Abstract LBA3500) Friday, May 30, 2:45-5:45 PM CDT First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): progression-free survival and updated overall survival analyses Elez et al BREAST CANCER Rapid Oral Presentation (Abstract 1020) Friday, May 30, 2:45-4:15 PM CDT Dose optimization of PF-07248144, a first-in-class KAT6 inhibitor, in patients (pts) with ER+/HER2− metastatic breast cancer (mBC): Results from phase 1 study to support the recommended phase 3 dose (RP3D) LoRusso et al Oral Presentation (Abstract LBA1000) Saturday, May 31, 1:15-4:15 PM CDT Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study Hamilton et al GENITOURINARY CANCERS Oral Presentation (Abstract 4502) Sunday, June 1, 9:45 AM-12:45 PM CDT Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) Gupta et al Oral Presentation (Abstract 5005) Tuesday, June 3, 9:45 AM-12:45 PM CDT ARCHES 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) Armstrong et al Poster Presentation (Abstract 4571) Monday, June 2, 9:00 AM-12:00 PM CDT EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) Bedke et al Poster Presentation (Abstract 5046) Monday, June 2, 9:00 AM-12:00 PM CDT Safety and pharmacokinetics of mevrometostat (M) in combination with enzalutamide (E) in patients with metastatic castration-resistant prostate cancer (mCRPC) Matsubara et al HEMATOLOGIC CANCERS Oral Presentation (Abstract 7504) Tuesday, June 3, 9:45 AM-12:45 PM CDT Elranatamab in combination with daratumumab and lenalidomide (EDR) in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant: Initial results from MagnetisMM-6 part 1 Quach et al THORACIC CANCERS Rapid Oral Presentation (Abstract 3010) Monday, June 2, 8:00-9:30 AM CDT Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001) Sehgal et al Poster Presentation (Abstract 6033) Monday, June 2, 9:00 AM-12:00 PM CDT Initial safety and efficacy of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC Gillison et al Poster Presentation (Abstract 8611) Saturday, May 31, 1:30-4:30 PM CDT Interim results of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in patients with NSCLC in a phase 1 trial Fontana et al *The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company. **Pfizer and Arvinas have a global collaboration for the co-development and co-commercialization of vepdegestrant. ***XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States. ****Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in patients with previously untreated metastatic urothelial cancer. Prescribing Information for Pfizer Medicines Please see full Prescribing Information for BRAFTOVI®. Please see full Prescribing Information, including BOXED WARNING, for ELREXFIO™ (elranatamab-bcmm). Please see full Prescribing Information for IBRANCE® (palbociclib) tablets and IBRANCE® (palbociclib) capsules. Please see full Prescribing Information, including BOXED WARNING, for PADCEV® (enfortumab vedotin). Please see full Prescribing Information for XTANDI® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice The information contained in this release is as of April 23, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and Pfizer’s oncology portfolio of marketed and investigational therapies, including their potential benefits; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data; the development or commercial potential of our product pipeline, in-line products, product candidates and additional indications or combinations, including expected clinical trial protocols, the potential and timing for the initiation and progress of clinical trials and data read-outs from trials; the timing and potential for the submission of applications for and receipt of regulatory approvals; the timing and potential for product launches and commercialization; expected breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; potential patients reached; the regulatory landscape; the competitive landscape; and other statements about our business, operations and financial results that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Phase 3ASCOPhase 1Clinical ResultImmunotherapy

100 Deals associated with Sigvotatug vedotin

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	United States	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Japan	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Argentina	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Australia	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Austria	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Belgium	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Brazil	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Bulgaria	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Canada	Pfizer Inc.	23 Jul 2025
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Chile	Pfizer Inc.	23 Jul 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06758401 (Sigvie-003, Pubmed \| Future Oncol)	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1 tumor proportion score ≥50%	714	Sigvotatug vedotin plus pembrolizumab	lmlkwqxqka(ogboctobhj) = nezgmljzel wyqwfvkrlj (zocgdqwyps, 18.4 - NR) View more	Positive	20 Dec 2025
				Pembrolizumab	utsvdtvnbw(dphvwyuyqi) = chhjvvmxmw jhnjqkrusc (evgjiddltn ) View more
NCT04389632 (SGNB6A-001, ASCO2025)	Phase 1	Pancreatic adenocarcinoma \| Ovarian Cancer \| Adenocarcinoma of Esophagus ... PD-L1 TPS \| PD-L1 CPS View more	31	Sigvotatug vedotin (SV) 1.8 mg/kg	ohxafpfsap(yeqbsjsrkc) = cuyqrdwtvx wtmttrnvkp (fbobudjzju ) View more	Positive	30 May 2025
NCT04389632 (SGNB6A-001, ASCO2024) Manual	Phase 1	Non-Small Cell Lung Cancer Integrin beta-6 (IB6)	113	Sigvotatug vedotin	qygxamnycj(rmipomjnpk) = spqfeakpgv egiszhjopl (xtrwianlau, 12.6 - 28.0) View more	Positive	24 May 2024
				Sigvotatug vedotin (1.8 mg/kg AiBW)	qygxamnycj(rmipomjnpk) = ijpnnmfqfg egiszhjopl (xtrwianlau, 8.6 - 42.3) View more
NCT04389632 (SGNB6A-001, ASCO 12023 \| ASCO 22023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	148	SGN B6A	eaxabagghu(ojsyshxndq) = wdnyfcpvhh sisjnrvcyg (kpcaaousdb ) View more	Positive	26 May 2023
				SGN B6A (NSCLC)	pxpydzjyri(mkrayifpjc) = fgnynqjetb wozeeoakyu (ckfpqqxbtt ) View more
NCT04389632 (SGNB6A-001, SITC2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	48	SGN-B6A (Q1W)	nktyobcjre(goiediepof) = tjeksiekip lpbukurxdx (wrtrcjdkfz )	Positive	01 Nov 2022
				SGN-B6A (2Q3W)	nktyobcjre(goiediepof) = stxqnruqpp lpbukurxdx (wrtrcjdkfz )

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