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NCT05109442 (AFM24 in Selected Advanced/Metastatic EGFR-expressing Cancers): BVCT ex-ante prediction vs. reported outcome

On 29 Feb 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. 2 readouts followed: 23 May 2024, True Negative (TN); 17 Dec 2024, True Negative (TN).

Clinical Trial

NCTID
NCT05109442
Drug Name
AFM24
Drug MoA
EGFR x CD16A tetravalent NK cell engager
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Selected Advanced/Metastatic EGFR-expressing Cancers
Human Patients
148
Sponsor
Affimed
Phase
Phase 1 Phase 2

Prediction of , index 428

Prospective Prediction
Prediction Index
428
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit for refractory/relapsed EGFRwt and EGFRmut solid tumors)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
84 days in advance
Readout Data Interpretation
6.6% ORR and 5.9 month PFS vs 35-50% ORR and 4.7-6.4 month PFS for SoC (nintedanib plus docetaxel VARGADO study doi- 10.1016/j.esmoop.2023.100879).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (non-superior to SoC)
Prediction Classification
True Negative (TN)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
292 days in advance
Readout Data Interpretation
FM24 + atezolizumab achieved 18% confirmed ORR (6/33) for EGFRwt advanced NSCLC patients; numerically inferior to pembrolizumab + ipilimumab that achieved 20-30% confirmed ORR (10.1016/j.lungcan.2018.12.015); AFM24 + atezolizumab achieved 24% confirmed ORR (4/17) for EGFRmut advanced NSCLC patients; inferior to osimertinib that achieved 71% ORR (10.1056/NEJMoa1612674)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak (in ORR) and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination With Atezolizumab in Patients With Selected Advanced/Metastatic EGFR-expressing Cancers
Phase
Phase 1, Phase 2
Status
Terminated
Enrollment
112
Lead sponsor
Affimed GmbH
Conditions
Advanced Solid Tumor
Interventions
DRUG: AFM24; DRUG: Atezolizumab 840 MG in 14 ML Injection
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2021-11-19
Primary completion
2025-03-06
Completion
2025-06-11
Results first posted
2025-08-20
Primary outcomes
  • Phase 1: Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1 (During cycle 1 (each cycle has 28 days))
  • Phase 2a: Overall Response Rate (Complete Response [CR] or Partial Response [PR]) (Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks.)

NCT05109442 on ClinicalTrials.gov

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How to read these records: evidence · methodology · all trials