ONCY Phase 1/2 (R/R) multiple myeloma (MM) AMBUSH trialThis investigator sponsored phase I/II trial is looking at the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory) (RRMM). https://clinicaltrials.gov/ct2/show/NCT05514990 In November 2022 GSK reported that its antibody drug conjugate (ADC) Blenrep (belantamab mafodotin) missed on its Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), the company announced Monday, possibly putting the drug’s continued approval at risk.
The DREAMM-3 study was a head-to-head superiority study that evaluated Blenrep alone compared to pomalidomide in combination with low-dose dexamethasone (PomDex). It failed to hit the primary endpoint of progression-free survival (PFS).
In the study, the median PFS for Blenrep was 11.2 months compared to 7 months for PomDex. Secondary endpoints included overall response rate (ORR), duration of response (DOR) and overall survival (OS). ORR was 41% for Blenrep, compared to 36% for PomDex. No new safety issues were identified.
https://www.biospace.com/article/gsk-s-multiple-myeloma-drug-blenrep-misses-mark-in-confirmatory-trial/ The GSK antibody-drug conjugate (ADC) Blenrep didn’t outdo Bristol Myers Squibb’s Pomalyst and low-dose dexamethasone at slowing disease progression or death.
The Dreamm- 3 study found Blenrep had no notable effects on progression-free survival, even though patients who got the GSK drug lived longer without disease progression at the median, going 11.2 months versus seven months. The discrepancy suggests a possible worsening of effect in the Blenrep arm after the median point.
https://www.fiercepharma.com/pharma/gsks-car-t-rival-blenrep-fails-multiple-myeloma-trial-endangering-fda-accelerated-approval