Trial: A Phase 3 Study to Evaluate Petosemtama…

Trial Details

Sponsor: Merus N.V. (industry)

Phase: 3

Start date: Sept. 25, 2024

Planned enrollment: 500

Trial ID: NCT06525220

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Petosemtamab (MCLA-158)

Overview

Petosemtamab (MCLA-158) is a human IgG1 bispecific antibody that targets EGFR and LGR5. It is being developed for epithelial tumors, with the most advanced program in recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). As of 2025, two phase 3 trials are enrolling in HNSCC: LiGeR‑HN1 (first‑line PD‑L1+ r/m HNSCC; petosemtamab + pembrolizumab vs pembrolizumab) and LiGeR‑HN2 (second/third‑line r/m HNSCC; petosemtamab vs investigator’s choice). The program has received FDA Breakthrough Therapy designation in pretreated HNSCC (May 2024) and for the petosemtamab+pembrolizumab first‑line PD‑L1+ setting (February 2025). (globenewswire.com, merus.gcs-web.com)

Mechanism of action

Dual targeting of EGFR and LGR5 with three complementary actions:
Blocks ligand binding to EGFR to inhibit downstream signaling.
Co-engagement of LGR5 promotes internalization and degradation of EGFR selectively in LGR5+ cancer cells.
Enhanced Fc effector function supports ADCC/ADCP against EGFR/LGR5‑expressing tumor cells. (pubmed.ncbi.nlm.nih.gov)

Preclinical studies in patient‑derived organoids and xenografts demonstrated tumor growth inhibition (including KRAS‑mutant CRC models), suppression of metastasis initiation, and activity across multiple epithelial cancers. (pubmed.ncbi.nlm.nih.gov)

Efficacy

Head and neck squamous cell carcinoma

First‑line, PD‑L1+ r/m HNSCC (petosemtamab + pembrolizumab; phase 2, NCT03526835)
ASCO 2025 interim update (data cutoff Feb 27, 2025; n=45 treated; n=43 evaluable): confirmed ORR 63% (27/43; 6 CRs, 21 PRs); median PFS 9.0 months (95% CI 5.2–12.9); 12‑month OS rate 79%; responses seen across PD‑L1 strata (CPS 1–19: 47%; CPS ≥20: 73%). Median DOR and OS not reached at cutoff. (ir.merus.nl, 1stoncology.com)
Earlier ASCO 2024 abstract (initial cutoff Nov 6, 2023): among 10 efficacy‑evaluable patients, early signals of activity were observed; study subsequently completed enrollment for the cohort. (ascopubs.org)
Second/third‑line r/m HNSCC (petosemtamab monotherapy; phase 1/2 expansion)
ESMO Asia 2024 update (single‑arm cohort; cutoff Nov 6, 2023): among 47 evaluable patients, ORR 40.4% (20/47 after confirmation), median DOR 7.2 months, median PFS 5.1 months, median OS 12.5 months. (oncologypro.esmo.org)
Dec 2024 press update (broader dataset; cutoff July 5, 2024): confirmed ORR 36% (27/75) in efficacy‑evaluable population; mDOR 6.2 months, mPFS 4.9 months, mOS 11.4 months; most mature subset (all 54 patients in earlier single‑arm cohort) showed mDOR 6.7, mPFS 5.1–5.2, mOS 12.0–12.5 months. (biospace.com)

Colorectal cancer

Phase 2 studies are enrolling: petosemtamab + chemotherapy in 1L/2L mCRC and monotherapy in heavily pretreated (3L+) mCRC (initial data expected in 2H 2025). No efficacy results have been reported yet. (globenewswire.com, merus.gcs-web.com)

Safety

Combination (1L PD‑L1+ r/m HNSCC; petosemtamab + pembrolizumab)
ASCO 2025 interim: generally manageable; grade ≥3 treatment‑emergent AEs in 60% (treatment‑related in 44%); infusion‑related reactions (IRRs) in 38% (grade 3 in 7%), predominantly during first infusion and resolved; no grade 4–5 IRRs. Earlier ASCO 2024 abstract also reported mostly grade 1–2 AEs with low early rates of severe toxicity. (ir.merus.nl, ascopubs.org)
Monotherapy (2L+ r/m HNSCC)
ESMO Asia 2024: common AEs included acneiform dermatitis (37% any grade; 3.7% grade 3–4), hypomagnesemia (35% any grade; 7.4% grade 3–4), rash (35% any grade; 0% grade 3–4); IRRs in 66.7% (22.2% grade 3–4), mostly first infusion; 9.3% discontinued due to day‑1 IRR. Program updates describe mitigation with adjusted administration to reduce IRR incidence/severity. (oncologypro.esmo.org, biospace.com)

Regulatory designations

FDA Breakthrough Therapy designation: (1) pretreated r/m HNSCC after platinum and PD‑(L)1 therapy (May 13, 2024); (2) first‑line PD‑L1+ r/m HNSCC for the petosemtamab+pembrolizumab combination (Feb 18, 2025). Earlier Fast Track designation was granted in August 2023 for the pretreated setting. (merus.gcs-web.com, globenewswire.com)

HealthScout AI Analysis

Goal: Evaluate whether adding petosemtamab to pembrolizumab improves outcomes versus pembrolizumab alone as first-line therapy in PD-L1–positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), and characterize safety, quality of life, pharmacokinetics, and immunogenicity.

Patients: Adults (≥18 years) with histologically confirmed recurrent or metastatic HNSCC of the oropharynx, oral cavity, hypopharynx, or larynx, not amenable to curative local therapy, PD-L1 CPS ≥1, ECOG 0–1, measurable disease by RECIST v1.1, and adequate organ function. No prior systemic therapy for incurable recurrent/metastatic disease; prior multimodal therapy for locally advanced disease allowed if progression occurred ≥6 months after last platinum. Prior anti–PD-(L)1 or anti-EGFR therapy not allowed, with limited exception for cetuximab given with RT if progression >1 year after last dose. Key exclusions include active/symptomatic CNS metastases, leptomeningeal disease, significant cardiac disease, uncontrolled comorbidities or infections, need for immunosuppression, active autoimmune disease requiring systemic therapy, and nasopharyngeal or sinonasal primaries.

Design: Phase 3, randomized, open-label, parallel-group study enrolling approximately 500 participants, allocated to combination therapy versus monotherapy as first-line treatment for PD-L1–positive r/m HNSCC. Global, industry-sponsored trial with blinded independent central review for efficacy endpoints and safety monitoring throughout treatment and follow-up of up to approximately 3 years.

Treatments: Experimental arm: petosemtamab plus pembrolizumab. Petosemtamab (MCLA-158) is a human IgG1 bispecific antibody targeting EGFR and LGR5. It blocks EGFR ligand binding and, via LGR5 co-engagement, promotes selective EGFR internalization/degradation in LGR5+ tumor cells, with enhanced Fc effector function to support ADCC/ADCP. Early-phase data in r/m HNSCC show encouraging activity: as first-line combination with pembrolizumab, interim reports noted high objective response rates and manageable safety; as monotherapy in pretreated settings, clinically meaningful responses and disease control were observed. Control arm: pembrolizumab monotherapy, a standard first-line option for PD-L1–positive r/m HNSCC.

Outcomes: Primary endpoints are overall survival and objective response rate per RECIST v1.1 by blinded independent central review. Key secondary endpoints include PFS, duration of response, clinical benefit rate, and corresponding investigator-assessed efficacy measures; safety endpoints include incidence of TEAEs, serious TEAEs, treatment discontinuations, and dose modifications. Additional endpoints encompass patient-reported health-related quality of life, pharmacokinetics during initial cycles, and incidence of anti-drug antibodies. Time frames generally extend up to approximately 2 years for efficacy/HRQoL and 30 days post–last dose for safety, with OS followed up to about 3 years.

Burden on patient: Moderate. Requirements include baseline and on-treatment tumor assessments by imaging per RECIST v1.1, a new tumor biopsy unless adequate archival tissue is available, and regular clinic visits for IV infusions. The combination arm adds infusion time and monitoring for infusion-related reactions, particularly during the first dose, and may necessitate electrolyte monitoring (for EGFR-related toxicities such as hypomagnesemia) and dermatologic management. Pharmacokinetic sampling is concentrated in the first six cycles, adding blood draws beyond standard care. Overall visit frequency and imaging schedules are typical for first-line immunotherapy trials; absence of complex dose-escalation procedures and limited long-term PK/ADA sampling keep the burden below that of early-phase studies but higher than standard monotherapy due to combination therapy and initial PK requirements.

Eligibility

Show Criteria

Inclusion Criteria:

1. Signed ICF before initiation of any study procedures

2. Age ≥ 18 years at signing of ICF

3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.

4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.

5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.

6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting

7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material

8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods

9. ECOG Performance Status (PS) of 0-1

10. Life expectancy ≥ 12 weeks, as per investigator assessment.

11. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan

12. Adequate organ function as defined per protocol.

13. HIV-positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is ≥ 300/µl, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy

Exclusion Criteria:

1. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization

2. Known leptomeningeal involvement

3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization

4. Requirement for immunosuppressive medication

5. Major surgery or radiotherapy within 3 weeks of randomization

6. Clinically significant toxicities related to prior anticancer therapies that have not returned to ≤ Grade 1 or baseline except for Grade ≤2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies

7. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.

8. Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment; or history of myocardial infarction within 6 months prior to randomization

9. History of prior malignancies within the last 5 years, with the exception of excised local cancer

10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy

11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders

12. Patients with known infectious diseases as per protocol.

13. Pregnant or breastfeeding patients.

14. The patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy of prednisone \>10 mg/day or equivalent, or any other form of immunosuppressive therapy

15. The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment

16. The patient has had an allogeneic tissue/solid organ transplant.

17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)

Other protocol defined inclusion/exclusion criteria may apply.

Sites (154)

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Site 46

Viedma, R8500ACE, Argentina

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CABA, C1118AAT, Argentina

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CABA, C1125ABD, Argentina

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Córdoba, X5008HHW, Argentina

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La Rioja, 5300, Argentina

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Rosario, S2000KZE, Argentina

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St Leonards, New South Wales, 2065, Australia

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Blacktown, New South Wales, 2148, Australia

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Melbourne, Victoria, 3004, Australia

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Leuven, 3000, Belgium

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Namur, 5000, Belgium

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Liège, 4000, Belgium

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Ghent, 9000, Belgium

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Edegem, 2650, Belgium

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Brussels, 1200, Belgium

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Rio de Janeiro, Rio de Janeiro, 22.250-905, Brazil

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Belo Horizonte, 30.360-680, Brazil

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Natal, 59020-340, Brazil

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Porto Alegre, 90610-000, Brazil

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Porto Alegre, 91350-200, Brazil

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São Paulo, 01509-900, Brazil

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Rio de Janeiro, 22281-100, Brazil

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São Paulo, 04538-132, Brazil

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Recife, 50040-000, Brazil

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Toronto, M5G 2M9, Canada

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Winnipeg, R3E0V9, Canada

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Santiago, 7560908, Chile

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Temuco, 76281055-7, Chile

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Santiago, 8330336, Chile

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Santiago, 7500921, Chile

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Recoleta, 8420000, Chile

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Providencia, 7500859, Chile

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Antofagasta, 1263521, Chile

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Lille, 59000, France

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Lyon, 69378, France

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Marseille, 13005, France

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Montpellier, 34298, France

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Nice, 06189, France

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Paris, 75005, France

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Paris, 75013, France

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Bordeaux, 33075, France

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Le Mans, 72000, France

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Poitiers, 86021, France

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Rouen, 76038, France

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Toulouse, 31100, France

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Vandœuvre-lès-Nancy, 54519, France

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Villejuif, 94800, France

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Dresden, 01307, Germany

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Hamburg, 22763, Germany

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Hanover, 30625, Germany

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Mannheim, 68167, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Ulm, 89075, Germany

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Würzburg, 97080, Germany

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Hamburg, 20251, Germany

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Bonn, 53175, Germany

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Greifswald, 17475, Germany

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Pátrai, Achaia, 265 04, Greece

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Heraklion, Crete, 715 00, Greece

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Panórama, 55236, Greece

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Chaïdári, 12462, Greece

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Haifa, 3109601, Israel

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Tel Aviv, 6423906, Israel

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Ramat Gan, 5266202, Israel

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Jerusalem, 9112001, Israel

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Ancona, 60126, Italy

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Rozzano, 20089, Italy

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Naples, 80131, Italy

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Naples, 80131, Italy

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Milan, 20141, Italy

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Milan, 20133, Italy

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Meldola, 47014, Italy

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Brescia, 25123, Italy

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Site 123

Kashiwa, Chiba, 277-8577, Japan

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Hiragi, Kagawa-ken, 761-0793, Japan

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Sendai, Miyagi, 960-8574, Japan

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Ōsaka-sayama, Osaka, 589-8511, Japan

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Chuo Ku, Tokyo, 104-0045, Japan

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Amsterdam, 1066 CX, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Utrecht, 3584 CX, Netherlands

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Krakow, 31-826, Poland

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Bydgoszcz, 85-796, Poland

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Gdansk, 80-214, Poland

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Gliwice, 44-102, Poland

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Seoul, 05505, South Korea

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Suwon, 16247, South Korea

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Seoul, 03722, South Korea

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Seoul, 03722, South Korea

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Hwasun, 58128, South Korea

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Gyeonggi-do, 13496, South Korea

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Goyang-si, 10408, South Korea

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Busan, 48108, South Korea

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Site 75

Madrid, 28040, Spain

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Pamplona, 31008, Spain

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Pamplona, 31008, Spain

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Valencia, 46009, Spain

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Barcelona, 08035, Spain

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Badalona, 08916, Spain

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Marbella, 29660, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Changhua, 500, Taiwan

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 40447, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Taoyuan, 333, Taiwan

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Ratchathewi, Bangkok, 10400, Thailand

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Bangkok Noi, Bangkok, 10700, Thailand

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Pathum Wan, Bangkok, 10330, Thailand

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Chiang Rai, Changwat Chiang Rai, 57000, Thailand

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Site 77

Hat Yai, Changwat Songkhla, 90110, Thailand

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Site 135

Taunton, TA1 5DA, United Kingdom

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London, EC1A 7BE, United Kingdom

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Site 102

Cambridge, CB20QQ, United Kingdom

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London, SE19RT, United Kingdom

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London, SW3 6JJ, United Kingdom

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Northwood, HA62RN, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Palo Alto, California, 94304, United States

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Los Angeles, California, 90033, United States

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La Jolla, California, 92037, United States

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Newark, Delaware, 19713, United States

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Washington D.C., District of Columbia, 20010, United States

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West Palm Beach, Florida, 33401, United States

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St. Petersburg, Florida, 33705, United States

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Orlando, Florida, 32827, United States

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Orlando, Florida, 32804, United States

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Fort Myers, Florida, 33901, United States

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Chicago, Illinois, 60637, United States

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Louisville, Kentucky, 40202, United States

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Hackensack, New Jersey, 07601, United States

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Albuquerque, New Mexico, 87131, United States

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Winston-Salem, North Carolina, 27157, United States

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Durham, North Carolina, 27710, United States

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Site 154

Philadelphia, Pennsylvania, 19114, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19104, United States

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Nashville, Tennessee, 37203, United States

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Chattanooga, Tennessee, 37404, United States

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Site 115

Memphis, Tennessee, 38103, United States

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Site 1

Houston, Texas, 77030, United States

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Austin, Texas, 78745, United States

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Site 15

Tyler, Texas, 75702, United States

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Sugarland, Texas, 77479, United States

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Plano, Texas, 75075, United States

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Site 10

Salt Lake City, Utah, 84112, United States

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Site 23

Norfolk, Virginia, 23502, United States

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Site 12

Blacksburg, Virginia, 24060, United States

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A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma

Trial Details

Show Summary from Sponsor

More details:

Investigational Drug AI Analysis

Show for: Petosemtamab (MCLA-158)

Overview

Mechanism of action

Efficacy

Safety

Further reading

HealthScout AI Analysis

Eligibility

Show Criteria

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