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NCT03526835 (Petosemtamab in 1L/2L/3L metastatic colorectal cancer): BVCT ex-ante prediction vs. reported outcome

BVCT made 2 dated predictions for this trial. On 14 Feb 2024 it predicted technical success and commercial success; 2 readouts followed: 23 May 2024, True Positive (TP); 22 May 2025, True Positive (TP). On 16 May 2025 it predicted technical success and commercial success; the 24 Oct 2025 readout is classified on the dashboard as True Positive (TP).

Clinical Trial

NCTID
NCT03526835
Drug Name
Petosemtamab (MCLA-158)
Drug MoA
anti-EGFR-LGR5 bispecific antibody
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
1L/2L/3L metastatic colorectal cancer (mCRC)
Human Patients
523
Sponsor
Merus
Phase
Phase 1 Phase 2

Prediction of , index 1462

Prospective Prediction
Prediction Index
1462
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit as 1L treatment in OS superior to chemo + pembrolizumab)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit as 1L treatment for HNSCC)
Indication (this prediction)
1L R/M HNSCC

Readout of

Prediction Validation
Readout Date
Prediction To Readout
99 days in advance
Readout Data Interpretation
67% ORR for combo superior to 27.3% ORR for SoC.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD (pending OS data)
Prediction Classification
True Positive (TP)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
463 days in advance
Readout Data Interpretation
petosemtamab + pembrolizumab achieved 63% ORR; 9 months mPFS; and 79% 12-month OS; superior to pembrolizumab + chemotherapy’s 36% ORR; 5.8 months mPFS; and 53% 12-month OS (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (ORR/PFS) and commercially sufficient (superior OS)
Prediction Classification
True Positive (TP)

Prediction of , index 2024

Prospective Prediction
Prediction Index
2024
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS for petosemtamab monotherapy moderately-to-strongly superior to FTD-TPI + bevacizumab in the 3L MSS mCRC clinical setting) SUCCESS (commercially sufficient clinical benefit in OS for petosemtamab + FOLFIRI/FOLFOX moderately superior to FOLFIRI/FOLFOX + bevacizumab in the 1L/2L MSS mCRC clinical setting)
Technical Prediction
SUCCESS (statistically significant clinical benefit in PFS/ORR for petosemtamab monotherapy non-inferior to FTD-TPI + bevacizumab in the 3L MSS mCRC clinical setting) SUCCESS (statistically significant clinical benefit in PFS/ORR for petosemtamab + FOLFIRI/FOLFOX slightly-to-moderately superior to FOLFIRI/FOLFOX + bevacizumab in the 1L/2L MSS mCRC clinical setting)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
161 days in advance
Readout Data Interpretation
Petosemtamab plus FOLFOX/FOLFIRI for 1L mCRC achieved 50-80% ORR (8/10 with 3 unconfirmed) slightly-to-moderately superior to 53% achieved by bevacizumab plus FOLFOX/FOLFIRI (see add'l link below); Petosemtamab plus FOLFOX/FOLFIRI for 2L mCRC achieved 46-62% cORR (6/13 with 2 unconfirmed) moderately-to-strongly superior to 11% achieved by bevacizumab plus FOLFOX/FOLFIRI (10.1093/annonc/mdv197); Petosemtamab mono therapy achieved 10% cORR (2/20) slightly superior to 6.1% cORR achieved by FTD–TPI plus bevacizumab (10.1056/NEJMoa2214963)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior-to-SoC ORR for 1L/2L/3L mCRC) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
560
Lead sponsor
Merus B.V.
Conditions
Advanced/Metastatic Solid Tumors; Colorectal Cancer; Gastric Cancer; Gastroesophageal-junction Cancer; NSCLC; HNSCC; Head and Neck Squamous Cell Carcinoma; Esophageal Cancer
Interventions
DRUG: MCLA-158; COMBINATION_PRODUCT: MCLA-158 + Pembrolizumab; COMBINATION_PRODUCT: MCLA-158 + FOLFIRI; COMBINATION_PRODUCT: MCLA-158 + FOLFOX
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2018-05-02
Primary completion
2028-05
Completion
2028-11
Primary outcomes
  • Escalation: Number of patients with Dose Limiting Toxicities (DLTs) during Cycle 1 (4 weeks)
  • Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer, and combination cohorts): Safety and tolerability: AEs and SAEs (6-12 months)
  • Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): Treatment discontinuations and dose modifications due to AEs (6-12 months)
  • Expansion (single agent - randomized expansion in 2/3L Head and Neck cancer): Best overall response (BOR) (36 months)
  • Expansion (Single agent - non-randomized, and combination cohorts): Objective response rate (ORR) (36 months)

NCT03526835 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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