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NCT05918445 (BNT327/PM8002 in advanced RCC): BVCT ex-ante prediction vs. reported outcome

On 9 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial failure 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 significant (against placebo) and commercially TBD.

Clinical Trial

NCTID
NCT05918445
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
advanced RCC
Human Patients
380
Sponsor
BioNTech
Phase
Phase 1 Phase 2

Prediction of , index 1732

Prospective Prediction
Prediction Index
1732
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS non-superior to pembrolizumab + lenvatinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
39 days in advance
Readout Data Interpretation
BNT327 achieved 25% cORR + 10.9-month mPFS as 2L for ccRCC; which is non-superior to 43% ORR + 14.6-month mPFS achieved by Lenvatinib + Everolimus (Lancet doi- 10.1016/S1470-2045(15)00290-9) and BNT327 achieved 36% cORR + 15.1-month mPFS as 1L for nccRCC; which is non-superior to 49% ORR + 17.9-month mPFS achieved by pembrolizumab + lenvatinib in KEYNOTE-B61 study (Lancet DOI- 10.1016/S1470-2045(23)00276-0).
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (against placebo) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
380
Lead sponsor
Biotheus Inc.
Conditions
Malignant Neoplasm
Interventions
DRUG: PM8002
Design
Sequential · None
Primary purpose
Treatment
Start
2021-03-09
Primary completion
2025-11-30
Completion
2025-11-30
Primary outcomes
  • Number of participants with DLTs (During the first three weeks of treatment with PM8002)
  • Treatment related adverse events (TRAEs) (Up to 30 days after last treatment)
  • Objective response rate (ORR) (Up to approximately 2 years)

NCT05918445 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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