LIGHTBEAM-U01 Substudy 01B: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

This study is a rolling arm study of pembrolizumab in combination with investigational agents in pediatric participants with relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) or tumor mutational burden-high (TMB-H). This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2). Participants will be assigned to a treatment arm (either Part 1 or Part 2) that is open for enrollment.
There will be no hypothesis testing in this study.

Start Date15 Jan 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT03598608

/ CompletedPhase 1/2

A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies

This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies:
* classical Hodgkin lymphoma (cHL)
* diffuse large B-cell lymphoma (DLBCL)
* indolent non-Hodgkin lymphoma (iNHL)
This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab administered as monotherapy in participants with cHL using a 1:1 randomized study design.
The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities.
There is no primary hypothesis for this study.

Start Date17 Oct 2018

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT03516981

/ CompletedPhase 2

A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

Start Date01 Oct 2018

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Favezelimab

100 Translational Medicine associated with Favezelimab

100 Patents (Medical) associated with Favezelimab

Literatures (Medical) associated with Favezelimab

01 Feb 2026·ANNALS OF ONCOLOGY

Novel pembrolizumab-based treatments as first-line therapy in advanced clear-cell renal cell carcinoma: substudy 03A of the open-label, umbrella platform, phase I/II KEYMAKER-U03 trial

Article

Author: Hammers, H ; Shin, S J ; Dziadziuszko, R ; Lee, J-L ; Suttner, L ; Miller, W H ; Peer, A ; Keizman, D ; Zwenger Kloster, A ; Powles, T ; Burgents, J E ; Rojas, C ; Waddell, T ; Weickhardt, A ; Motzer, R ; Suarez, C ; Yanez Weber, P ; Neiman, V ; Albiges, L ; Sharma, M

BACKGROUND:

First-line triplet therapy may expand clinical benefit for advanced clear-cell renal cell carcinoma (ccRCC). The phase Ib/II KEYMAKER-U03 substudy 03A (NCT04626479) investigated novel pembrolizumab (pembro)-based regimens in this setting.

PATIENTS AND METHODS:

Participants with advanced ccRCC and no prior systemic therapy were randomized 2 : 1 to quavonlimab (qmab)/pembro plus lenvatinib (lenva), favezelimab (fave)/pembro plus lenva, pembro plus lenva plus belzutifan (bel), and vibostolimab (vibo)/pembro plus bel or a concurrent reference treatment (pembro plus lenva). A safety lead-in of ∼10 participants occurred for all investigative treatments before randomization. Primary endpoints were objective response rate (ORR) per RECIST v1.1 by blinded independent central review in all randomized participants (excluding safety lead-in), and safety in all treated participants. Secondary endpoints included progression-free survival (PFS) and overall survival (OS).

RESULTS:

As of 31 March 2025, 393 participants were enrolled. Median follow-up for randomized participants across the five cohorts ranged between 16 and 39 months. The ORR was 80.6% [95% confidence interval (CI) 68.6% to 89.6%] with pembro plus lenva, 71.3% (95% CI 60.0% to 80.8%) with qmab/pembro plus lenva, 62.7% (95% CI 48.1% to 75.9%) with fave/pembro plus lenva, 77.5% (95% CI 66.8% to 86.1%) with pembro plus lenva plus bel, and 42.5% (95% CI 31.5% to 54.1%) with vibo/pembro plus bel. Median PFS was 26.3 months (95% CI 15.3-39.8 months) with pembro plus lenva, 18.0 months (95% CI 11.6-34.3 months) with qmab/pembro plus lenva, 26.0 months (95% CI 8.2-31.8 months) with fave/pembro plus lenva, 31.8 months [95% CI 26.3 months-not reached (NR)] with pembro plus lenva plus bel, and 15.2 months (95% CI 12.4 months-NR) with vibo/pembro plus bel. Median OS was not reached in any arm. Grade ≥3 treatment-related adverse events occurred in 71.0% (44/62) of participants treated with pembro plus lenva, 73.3% (66/90) with qmab/pembro plus lenva, 86.9% (53/61) with fave/pembro plus lenva, 70.0% (63/90) with pembro plus lenva plus bel, and 68.9% (62/90) with vibo/pembro plus bel.

CONCLUSIONS:

Observed efficacy and safety of pembro plus lenva were confirmatory of prior observations for this combination. ORR was similar to reference for pembro plus lenva plus bel and qmab/pembro plus lenva, but not the other investigative arms. Further investigation of pembro plus lenva plus bel and qmab/pembro plus lenva versus pembro plus lenva is ongoing in the phase III LITESPARK-012 study.

14 Oct 2025·Blood Advances

Estimating efficacy of favezelimab plus pembrolizumab relative to pembrolizumab in anti–PD-1–refractory Hodgkin lymphoma

Article

Author: Pillai, Pallavi ; Lavie, David ; Herrera, Alex F. ; Timmerman, John ; Armand, Philippe ; Thiagarajan, Kannan ; Johnson, Nathalie A. ; Topp, Brian G. ; Zinzani, Pier Luigi

Abstract:

Favezelimab plus pembrolizumab had promising efficacy in anti–programmed cell death protein 1 (PD-1)–refractory classical Hodgkin lymphoma in MK-4280-003; however, the contribution of favezelimab was unclear. Here, we assessed the relative contribution of favezelimab by comparison with data from participants treated with only pembrolizumab beyond progression in KEYNOTE-087. Participants in MK-4280-003 had received ≥2 doses of anti–PD-1 therapy and progressed <12 weeks of last dose. Participants eligible from KEYNOTE-087 had received >2 doses of pembrolizumab beyond progression, and progressed <12 weeks of last dose. Participants received pembrolizumab 200 mg plus favezelimab 200 mg or 800 mg, or pembrolizumab 200 mg IV every 3 weeks. Change in target lesion size and response per International Working Group 2007 criteria were assessed. Baseline tumor size was reset at first progression for KEYNOTE-087. A bootstrapping method compared change in target lesion size between groups. Twenty-seven participants from MK-4280-003 and 81 from KEYNOTE-087 were included. Objective response rates were 37% (95% confidence interval [CI], 15-51) for favezelimab plus pembrolizumab, and 2% (95% CI, 0-6) for pembrolizumab alone. A clinically meaningful reduction (≥50%) in target lesion size was observed in 13 (48%) vs 4 participants (5%), respectively. The mean change from baseline in target lesion size was −49% and −0.4%. In the bootstrapping analysis, 99.4% of samples showed greater decrease in tumor burden with favezelimab plus pembrolizumab. Favezelimab plus pembrolizumab had a higher response rate and greater reduction in tumor burden vs pembrolizumab alone in anti–PD-1–refractory classical Hodgkin lymphoma, suggesting favezelimab contributed substantially to efficacy in MK-4280-003. The trials were registered at www.clinicaltrials.gov as #NCT03598608 and #NCT02453594.

01 Jul 2023·Nature medicineQ1 · MEDICINE

Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results

Q1 · MEDICINE

Article

Author: Yuan, Jianda ; Snyder, Alexandra ; Gutierrez, Martin ; Palcza, John ; Kobie, Julie ; Luft, Alexander ; Felip, Enriqueta ; Tan, Daniel Shao Weng ; Hellmann, Matthew D ; Cristescu, Razvan ; Landers, Gregory A ; Basso, Andrea ; Herbst, Roy S ; Ahn, Myung-Ju ; Gubens, Matthew A ; Ma, Hua ; Lee, Jong-Seok ; Finocchiaro, Giovanna ; Lam, Wei-Sen ; Chiu, Joanne W Y ; Fong, Lawrence ; Garon, Edward B ; Aggarwal, Charu ; Yang, James Chih-Hsin

Although pembrolizumab confers clinical benefit in non-small cell lung cancer (NSCLC), only a subset of patients will respond due to a heterogenous tumor microenvironment. KEYNOTE-495/KeyImPaCT is an ongoing biomarker-directed, adaptively randomized phase 2 study investigating first-line pembrolizumab (200 mg every 3 weeks) + lenvatinib (20 mg daily), anti-CTLA-4 quavonlimab (25 mg every 6 weeks) or anti-LAG-3 favezelimab (200 mg or 800 mg every 3 weeks) in advanced NSCLC. Patients were categorized by T-cell-inflamed gene expression profile (Tcell_infGEP) and tumor mutational burden (TMB) status and randomly assigned 1:1:1 to receive pembrolizumab + lenvatinib, pembrolizumab + quavonlimab or pembrolizumab + favezelimab. The primary outcome was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 using pre-specified efficacy thresholds for each biomarker-defined subgroup (>5% (Tcell_infGEP^lowTMB^non-high (group I)), >20% (Tcell_infGEP^lowTMB^high (group II) and Tcell_infGEP^non-lowTMB^non-high (group III)) and >45% (Tcell_infGEP^non-lowTMB^high (group IV))). Secondary outcomes were progression-free survival, overall survival and safety. At data cutoff, ORR ranges were 0-12.0% in group I, 27.3-33.3% in group II, 13.6-40.9% in group III and 50.0-60.0% in group IV. ORR with pembrolizumab + lenvatinib in group III met the pre-specified efficacy threshold. The safety profile of each treatment arm was consistent with the known safety profile of each combination. These data demonstrate the feasibility of prospective Tcell_infGEP and TMB assessment to study the clinical activity of first-line pembrolizumab-based combination therapies in advanced NSCLC. ClinicalTrials.gov registration: NCT03516981 .

News (Medical) associated with Favezelimab

30 Oct 2025

·www.prnewswire.com

Clinical Late-Breaking Abstracts Announced for the Society for Immunotherapy of Cancer's 40th Anniversary Annual Meeting

MILWAUKEE, Oct. 30, 2025 /PRNewswire/ -- The Society for Immunotherapy of Cancer (SITC) received an incredible number of abstract submissions in 2025, more than 1,300, including many clinical based Late-breaking Abstracts. SITC is proud to announce the titles and authors for the clinical Late-breaking Abstracts (LBA) . The abstracts will be presented at SITC's upcoming 40th Anniversary Annual Meeting & Pre-Conference Programs taking place Nov. 5–9, 2025, in National Harbor, MD and virtually. Continue Reading SITC 2025 Logo "We are excited to incorporate these clinical abstracts into an already impressive lineup of abstracts that will be presented at SITC. The Late-breaking Abstracts this year will only focus on late-breaking data from interventional clinical trials in humans and will further enhance the cutting-edge science offered at the 40th Anniversary Annual Meeting," said SITC Vice President Sandra Demaria MD. "SITC is committed to accelerating the approval of 100 novel agents by 2034, and providing a platform to showcase the latest clinical advancements at our Annual Meeting is an important component of this goal." The Late-breaking Abstracts with oral presentations at the 40th Anniversary Annual Meeting are: (1316) Initial monotherapy clinical activity of invikafusp alfa, a first-in-class TCR β-chain-targeted bifunctional antibody, in tissue-agnostic, TMB-H patients from STARt-001, a Phase 1/2 trial Aurélien Marabelle, MD, PhD – Gustave Roussy & Paris Saclay University Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1342) First-in-human dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and initial efficacy of mRNA-LNP MT-302 in vivo CAR therapy in solid tumors Rasha Cosman, BSc (Med), MBBS, FRACP – St. Vincent's Hospital Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1348) Final overall survival analysis of HARMONi-A study comparing ivonescimab plus chemotherapy to chemotherapy alone in patients with EGFR+ NSCLC progressed on EGFR-TKI treatment Li Zhang, MD – Sun Yat-Sen University Cancer Center Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1305) Coformulation of favezelimab and pembrolizumab as neoadjuvant therapy for resectable cutaneous squamous cell carcinoma (cSCC): results from cohort A of the phase 2 KeyForm-010 study Matteo Carlino, MBBS, PhD, BMedSC, FRACP – The University of Sydney Session 106a: Considerations for Incorporating Biomarkers in Perioperative/Neoadjuvant Therapy – Friday, Nov. 7, 2025 – 1:45 p.m. ET (1346) Molecular and immunologic correlates of response in a phase II study of neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma Kenneth Tsai, MD, PhD – Moffitt Cancer Center Session 106a: Considerations for Incorporating Biomarkers in Perioperative/Neoadjuvant Therapy – Friday, Nov. 7, 2025 – 1:45 p.m. ET (1327) Biomarker and updated clinical data for RP1 plus nivolumab in anti-PD-1-failed melanoma from the IGNYTE trial demonstrate reversal of mechanisms of resistance to immune checkpoint blockade Trisha Wise-Draper, MD, PhD– University of Cincinnati Cancer Center Session 107d: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics – Friday, Nov. 7, 2025 – 3:55 p.m. ET (1328) SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): results from a phase 2 study Lin Wu, PhD –Hunan Cancer Hospital Session 107d: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics – Friday, Nov. 7, 2025 – 3:55 p.m. ET (1310) A phase 1/IIa study of ILKN421H, a LNP mRNA encoding an IL2Rβγ selective IL-2v, as monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors Haining Huang, PhD- ILeukon Therapeutics Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1325) SCOPE, an open label phase 2 parallel multi cohort clinical trial evaluating an off-the-shelf DNA plasmid vaccine in first line advanced melanoma combined with check point blockade - interim read-out Nermeen Varawalla, MD, PhD, MBA – Scancell Ltd Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1336) Final ph1b/2 results for Nous-209 monotherapy in Lynch syndrome carriers: Annual revaccination boosts T cell immunity informing future cancer interception strategies Anna Morena D'Alise, PhD – Nouscom SRL Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1340) Lead-in therapy targeting PD1 and/or LAG3 distinguishes differential impacts upon the immune response in first-line treatment of metastatic melanoma Lilit Karapetyan, MD – Moffitt Cancer Center Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1345) Initial phase 1a/1b results of STK-012, an α/β IL-2 receptor biased partial agonist, with pembrolizumab, pemetrexed, and carboplatin in 1L PD-L1 negative non-squamous NSCLC Adam Schoenfeld, MD – Memorial Sloan-Kettering Cancer Center Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET The full Regular and Young Investigator Award abstracts will be available on Nov. 4 at 9 a.m. ET and LBA – Clinical Only abstracts will be made available on Nov. 7 at 9 a.m. ET. Both types of abstracts will be published in the Journal for ImmunoTherapy of Cancer (JITC) Clinical Late-breaking Abstract Sessions with oral abstract presentations will take place on Friday, Nov. 7 from 11:30 a.m.–12:15 p.m. CT and Saturday, Nov. 8 from 1:45–3 p.m. ET in the Gaylord National Resort and Convention Center - Ballroom Level - Potomac Ballroom. In addition, Late-breaking Abstract posters will be presented in the Exhibit and Poster Hall and the virtual ePoster Hall beginning Friday, Nov. 7 at 10 a.m. ET. To learn more about the Late-breaking Abstracts, visit the 40th Annual Meeting & Pre-Conference Programs website. To register for the 40th Anniversary Annual Meeting and Pre-Conference Programs, click here. About SITC The Society for Immunotherapy of Cancer (SITC) is the world's leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Established in 1984, SITC, a 501(c)(3) not-for-profit organization, serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Through educational programs that foster scientific exchange and collaboration, SITC aims to one day make the word cure a reality for cancer patients everywhere. To learn more, visit and follow us on X, LinkedIn, Facebook and YouTube. SOURCE Society for Immunotherapy of Cancer (SITC) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultImmunotherapyVaccine

14 Feb 2025

·endpts.com

Bristol Myers’ Opdualag stumbles in late-stage resected melanoma trial

Bristol Myers Squibb’s LAG-3/PD-1 targeting immunotherapy Opdualag failed to boost survival in patients with advanced skin cancer in a Phase 3 study, marking the latest flop for an approach that has a patchy study record so far. The company’s fixed-dose combination of relatlimab and Opdivo given as an adjuvant treatment did not meet the recurrence-free survival primary endpoint in the Phase 3 RELATIVITY-098 trial of people with completely resected stage 3 to 4 melanoma. The study set the treatment against Opdivo monotherapy in more than 1,000 participants, according to a Thursday release . The fixed-dose combination won FDA approval in unresectable or metastatic melanoma three years ago. Sales of the immunotherapy last year grew 48% from 2023 to reach $928 million . On Thursday, Leerink analysts said the recent failure is notable because the adjuvant setting in RELATIVITY-098 “presents a significant opportunity, with nearly twice the market size of first-line metastatic melanoma.” But they maintained their models of $1.9 billion in Opdualag peak sales by the end of 2028 — a more conservative projection than the Wall Street consensus of $2.5 billion in 2035. The lower sales estimate factors in potential competition from Regeneron’s fixed-dose combination of LAG-3 antibody fianlimab and PD-1 drug Libtayo, the Leerink analysts said. Regeneron’s candidate is in a Phase 3 study in high-risk melanoma that’s been surgically removed, with topline data expected in 2028. It hasn’t been all smooth sailing for the LAG-3/PD-1 dual targeting approach. In September last year, there was skepticism about positive Phase 2 lung cancer data for Opdualag because some believed it was based on an analysis of “cherry-picked” patients . Later that month, Merck’s LAG-3 drug favezelimab added to Keytruda didn’t improve overall survival in certain patients with colorectal cancer in a Phase 3 trial. In July, Incyte terminated four programs , including a LAG-3 monoclonal antibody and a LAG-3xPD-1 bispecific, citing the evolving treatment landscape. In 2023, Bristol Myers ended a late-stage study of Opdualag in colorectal cancer after a data monitoring committee said it was unlikely to meet its primary endpoints.

Phase 3ImmunotherapyClinical Result

27 Dec 2024

·www.echemi.com

Merck Halts TIGIT/LAG-3 Project, Shifts Focus to $2 Billion Oral GLP-1 Drug Collaboration

On December 16, Merck announced on its official website that it has officially stopped the development of the anti-TIGIT antibody Vibostolimab and the anti-LAG-3 antibody Favezelimab. This decision marks the end of Merck's years of effort in the field of immune checkpoint inhibitors. Two days later, on December 18, Merck announced its new strategic direction by reaching a collaboration agreement with domestic company Hansoh Pharmaceutical. According to the agreement, Merck will obtain global exclusive licensing rights for Hansoh’s oral small molecule GLP-1 receptor agonist HS-10535, while Hansoh will retain control of the drug in the Chinese market. The total amount of this collaboration is as high as $2 billion. This series of business adjustments reflects Merck's concerns about the impending patent cliff for its main product, Pembrolizumab (Keytruda). At the same time, these adjustments provide clues about future competitive focuses for innovative pharmaceutical companies. Vibostolimab, which Merck has discontinued, is an antibody drug targeting the TIGIT site. TIGIT is an inhibitory receptor expressed on T cells and NK cells, belonging to the immunoglobulin superfamily. Vibostolimab aims to block the TIGIT signaling pathway to enhance the body's immune response against tumor cells. Although TIGIT is regarded as a potential therapeutic target, Merck and several other pharmaceutical companies like Roche have conducted long-term development in this area but have not achieved success. Vibostolimab faced failures in multiple clinical trials, including the KeyVibe-002 trial in patients with metastatic non-small cell lung cancer (NSCLC) and studies in high-risk melanoma patients. Similarly, Merck's other drug Favezelimab is an antibody drug targeting the LAG-3 site, aiming to restore the effector function of T cells. Despite several clinical studies, including the Phase III KEYFORM-007 study in PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients, Favezelimab also failed to meet its primary endpoint, leading Merck to decide to terminate its clinical development program. After abandoning Vibostolimab and Favezelimab, Merck's next research focus shifts to the oral small molecule GLP-1 receptor agonist HS-10535. GLP-1 related products, as weight loss drugs, hold significant appeal for pharmaceutical companies. Novo Nordisk and Eli Lilly have already reaped substantial profits from their GLP-1 products. Merck began its layout in the GLP-1 project back in 2010, but has yet to successfully launch a product. This collaboration with Hansoh Pharmaceuticals may provide Merck with an opportunity to break through in this field. Currently, the oral Semaglutide tablet (Rybelsus) is the only marketed oral GLP-1 drug, utilizing SNAC technology to facilitate transcellular absorption through the gastric mucosa. Eli Lilly’s Orforglipron is leading the field of oral GLP-1 receptor agonists, while domestic companies such as Heng Rui Medicine's HRS-7535 and Wenshan Medicine's VCT220 are also actively developing. With the impending expiration of the Keytruda patent, Merck is under pressure to find its next blockbuster. Despite setbacks in the research of TIGIT, LAG-3, and GLP-1 targets, Merck's bet on oral GLP-1 small molecule drugs may provide it with a chance to overtake competitors.

License out/inPhase 3ImmunotherapyADC

100 Deals associated with Favezelimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Classical Hodgkin's Lymphoma	Phase 3	Sweden	Merck Sharp & Dohme LLC	29 Aug 2022
Refractory Classic Hodgkin Lymphoma	Phase 3	Sweden	Merck Sharp & Dohme LLC	29 Aug 2022
Metastatic Colorectal Carcinoma	Phase 3	Norway	Merck Sharp & Dohme LLC	24 Sep 2021
Solid tumor	Phase 3	United States	Merck Sharp & Dohme Corp.	21 Aug 2018
Solid tumor	Phase 3	China	Merck Sharp & Dohme Corp.	21 Aug 2018
Solid tumor	Phase 3	Japan	Merck Sharp & Dohme Corp.	21 Aug 2018
Solid tumor	Phase 3	Argentina	Merck Sharp & Dohme Corp.	21 Aug 2018
Solid tumor	Phase 3	Australia	Merck Sharp & Dohme Corp.	21 Aug 2018
Solid tumor	Phase 3	Austria	Merck Sharp & Dohme Corp.	21 Aug 2018
Solid tumor	Phase 3	Belgium	Merck Sharp & Dohme Corp.	21 Aug 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03598608 (ASCO2024) Manual	Phase 1/2	Refractory Classic Hodgkin Lymphoma	34	Favezelimab + Pembrolizumab	dykwwrkonr(qmmfhmvhsv) = ksdkmyvwad qtzuvzykys (ifptogwmxr ) View more	Positive	24 May 2024
NCT03598608 (ASCO2024) Manual	Phase 1/2	Refractory Classic Hodgkin Lymphoma	34	Favezelimab + Pembrolizumab (With anti–PD-1 as most recent therapy)	tunfgwaqop(gqekjdrbvg) = yxxdmrbajs tfjrezorxt (bglqmstjnf, 14 - 62)	Positive	24 May 2024
NCT03598608 (ASCO2024)	Phase 1/2	Relapsing classical Hodgkin lymphoma LAG-3	30	Pembrolizumab 200 mg IV Q3W plus favezelimab 200-mg starting dose	iiiolpwhzn(wekclpzkhi) = lagmwtznhx djqbosvrgq (gapsmwgmjp, 65 - 94) View more	Positive	24 May 2024
NCT03598608 (MK-4280-003, EHA2024)	Phase 1/2	Refractory Indolent Non-Hodgkin Lymphoma	24	Favezelimab plus Pembrolizumab	dhnhoktjch(qqzvjwkfju) = tbopuckkyj zeotgustkn (uzsafxupdc, 8 - 44) View more	Positive	14 May 2024
NCT03598608 (4280-003 \| MK-4280-003, ASH2023)	Phase 1/2	Refractory Classic Hodgkin Lymphoma	34	Favezelimab + Pembrolizumab	gzuhjcryfd(jlthcnrphe) = geuzpxfgmz pylmubkijh (ekvxufkzjg, 15 - 48) View more	-	11 Dec 2023
NCT03598608 (4280-003 \| MK-4280-003, ASH2023)	Phase 1/2	Diffuse large B-cell lymphoma recurrent	25	Favezelimab 800 mg	ssiqfxcmvj(lqsmehanqp) = rogwltidmf coqsbmxsuu (wbekyuafue, 2.5 - 31.2) View more	-	09 Dec 2023
NCT03598608 (4280-003 \| MK-4280-003 \| Phase 1/2 Study, ASH2023)	Phase 1/2	Refractory Classic Hodgkin Lymphoma	30	Favezelimab 800 mg + Pembrolizumab 200 mg	hwuqolinyh(slwujocgdw) = pkrvirzjbv olalawgowg (rwjyprijky, 61 - 92) View more	-	09 Dec 2023
NCT03598608 (ICML2023)	Phase 1/2	Relapsing classical Hodgkin lymphoma anti-PD-1	-	Favezelimab plus Pembrolizumab	oomwvqsstk(ijknuvdavu) = iafqvbehpt yelrgtktyr (knnoisovau ) View more	Positive	09 Jun 2023
NCT03598608 (MK-4280-003, ICML2023)	Phase 1/2	Hodgkin's Lymphoma \| Hematologic Neoplasms \| B-Cell Lymphoma ... anti-PD-1-refractory View more	33	Favezelimab + Pembrolizumab	okevuqaymq(jwomzqyvtb) = qhawzojuzs qeipvzfkae (yawomvgluc, 15 - 51)	Positive	09 Jun 2023
NCT03598608 (MK-4280-003, ICML2023)	Phase 1/2		33	Pembrolizumab	okevuqaymq(jwomzqyvtb) = pgxmhnwamu qeipvzfkae (yawomvgluc, 0 - 5.9)	Positive	09 Jun 2023
NCT03598608 (4280-003 \| MK-4280-003, EHA2023)	Phase 1/2	Hodgkin's Lymphoma \| B-Cell Lymphoma \| Hematologic Neoplasms	-	Favezelimab + Pembrolizumab	ftegghztbi(ndkdbmpwwq) = nizwmodzyn fmkztodgsz (gctkvokyec, 61 - 92) View more	-	08 Jun 2023
NCT03598608 (4280-003 \| MK-4280-003, EHA2023)	Phase 1/2	Hodgkin's Lymphoma \| Hematologic Neoplasms \| B-Cell Lymphoma	34	Favezelimab + Pembrolizumab	jngflhgrdt(keijgflual) = jnuhjlihga zjxkzapkut (uijbfkjeto, 15 - 48) View more	-	08 Jun 2023

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