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NCT05756972 (BNT327/PM8002 in Non-Small-Cell Lung): BVCT ex-ante prediction vs. reported outcome

On 9 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 17 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant (slightly higher ORR with inferior tolerability) and commercially TBD.

Clinical Trial

NCTID
NCT05756972
Drug Name
BNT327/PM8002
Drug MoA
anti-PDL1 and anti-VEGF bsAb
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Non-Small-Cell Lung
Human Patients
374
Sponsor
BioNTech
Phase
Phase 2 Phase 3

Prediction of , index 1731

Prospective Prediction
Prediction Index
1731
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate additive clinical benefit in OS numerically superior to carboplatin + pemetrexed combotherapy)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in ORR/PFS non-superior to carboplatin + pemetrexed combotherapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
39 days in advance
Readout Data Interpretation
BNT327 + chemotherapy achieved 37% cORR; numerically superior to 29% cORR achieved by chemotherapy alone; BNT327 + chemotherapy achieved 61% Grade 3 TEAE; inferior to 20-40% Grade 3 TEAE achieved by chemotherapy alone (see 10.1177/1758834016644155).
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant (slightly higher ORR with inferior tolerability) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002(Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With EGFR-mutant Advanced Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment
Phase
Phase 2
Status
Active not recruiting
Enrollment
64
Lead sponsor
Biotheus Inc.
Conditions
NSCLC
Interventions
DRUG: PM8002; DRUG: Carboplatin; DRUG: Pemetrexed
Design
Single group · None
Primary purpose
Treatment
Start
2023-06-26
Primary completion
2024-09-13
Completion
2025-12
Primary outcomes
  • Objective response rate (ORR) (Up to approximately 2 years)

NCT05756972 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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