CLINICAL AND REGULATORY
GSK makes checkpoint progress as PD-1, TIM3 programs advance
The company said the 243-patient study, previously described as a non-inferiority trial, was not designed to demonstrate superiority. First-line NSCLC would represent a significant label expansion for Jemperli, though the PD-1 inhibitor would face heavy competition from the class’s blockbusters Keytruda and Opdivo. FDA approved Jemperli last August as second-line therapy for mismatch repair-deficient recurrent endometrial cancers and other solid tumors with no alternative treatments. Regardless of how well Jemperli competes in the first-line setting, monotherapy efficacy in the indication helps build GSK’s case for next-generation checkpoint inhibitor combinations involving the PD-1 blocker. GSK also announced that it is advancing anti-TIM3 mAb cobolimab into the Phase 3 part of the Phase 2/3 COSTAR study after meeting the prespecified expansion criteria. The trial is evaluating cobolimab plus Jemperli and chemotherapy against Jemperli and chemotherapy or chemotherapy alone in NSCLC patients who had progressed on a prior anti-PD-1 therapy.
Pfizer’s PARP combo meets in Phase 3 in mCRPC patients
Phase 3 data from the TALAPRO-2 trial could move Talzenna talazoparib from Pfizer a step closer to regulatory submissions in mCRPC. The readout showed that Talzenna plus Xtandi enzalutamide improved radiographic PFS compared with placebo plus Xtandi in mCRPC patients with or without homologous recombination repair gene mutations, meeting the primary endpoint. Preliminary data also showed a trend toward improved overall survival, a secondary endpoint. Talzenna, a PARP inhibitor, was FDA approved in 2018 to treat adults with deleterious germ-line BRCA-mutated HER2-negative breast cancer.
Imjudo approved in combination with Imfinzi for liver cancer
The combination of PD-L1 blocker Tecentriq atezolizumab and anti-VEGF agent Avastin bevacizumab from Roche will now face competition from Imjudo tremelimumab from AZ after FDA’s approval of the CTLA-4 blocker plus anti-PD-1 mAb Imfinzi durvalumab to treat first-line, unresectable HCC. The approval marks Imjudo’s first worldwide; the Imjudo-Imfinzi combination is also under review in Europe, Japan and other countries to treat patients with advanced liver cancer. CTLA-4 inhibitor Yervoy ipilimumab from BMS is approved for HCC, but not in the first-line setting.
FDA approves J&J’s Tecvayli, first bispecific T cell engager for multiple myeloma
FDA’s accelerated approval of Tecvayli teclistamab-cqyv from JNJ to treat patients with refractory multiple myeloma who have received at least four prior lines of therapy marks the agency’s first of a bispecific T cell engager to treat the disease. It’s Janssen’s fourth FDA-approved multiple myeloma drug, and the first T cell engaging bispecific antibody to reach the European or US markets since the 2016 approval of Blincyto blinatumomab from Amgen. The EC approved Tecvayli, which targets CD3 x BCMA, in August.
Merck ends development of oncolytic virus from Viralytics deal
In its 3Q22 earnings report, Merck & Co. disclosed that it is no longer advancing V937, an oncolytic virus that had been in Phase 2 development to treat solid tumors. Merck said it had discontinued the program as part of its routine pipeline prioritization. The pharma had obtained the program via its 2018 acquisition of Viralytics for $398 million.