Opdivo approved as first immunotherapy for first-line advanced gastric cancer in China

FDA accepts Beigene’s first filing outside China; BLA seeks nod for anti-PD-1 tislelizumab

FDA has accepted for review Novartis and Beigene’s BLA filing for the anti-PD-1 monoclonal antibody tislelizumab. This marks the first regulatory filing for tislelizumab outside of China, where it has already chalked up approvals for five indications. The BLA is seeking approval for the candidate’s use in treating unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma in people who had received prior systemic therapy.

CLINICAL

Positive readut for a subcutaneous bispecific antibody from Genmab

Epcoritamab, a subcutaneously administered CD3 x CD20 bispecific antibody from Genmab, led to an 88% ORR in relapsed or refractory diffuse B cell lymphoma patients, providing support that the formulation may compete with more burdensome IV infusions on efficacy. Among eight patients who received the recommended Phase II dose of 48 mg, 38% achieved a complete response. ORR was 90% and CR was 50% in the 10 follicular lymphoma patients treated across dose ranges in the dose-escalation study. There was no Grade 3 of higher cytokine release syndrome. Odronextamab (REGN1979), a CD3 x CD20 bispecific from Regeneron, led to an ORR of 92.9% in follicular lymphoma patients in a Phase I readout last year, though a partial clinical hold was place on the program in December due to incidence of Grade 3 and higher CRS during step-up dosing.

CStone presents positive Phase 3 data of sugemalimab for NSCLC

Cstone Pharmaceuticals released positive data from the phase 3 trial, Gemstone-302, of sugemalimab plus chemotherapy for the first-line treatment of patients with stage IV squamous and non-squamous NSCLC. The trial enrolled 479 patients, with 79 (24.7%) still on treatment in the sugemalimab plus chemotherapy group versus 12 (7.5%) in the placebo plus chemotherapy group. The median PFS was nine months for sugemalimab plus chemotherapy versus 4.9 months for placebo plus chemotherapy in patients with both squamous and non-squamous NSCLC. It was 8.3 months versus 4.8 months in patients with squamous and 9.6 months vs 5.9 months in patients with non-squamous. The median OS was 22.8 months for sugemalimab versus 17.7 months for placebo, although the OS events have not met the pre-defined interim analysis plan. The OS events took up 55% of the pre-defined number of events at OS final analysis.

Coherus readying toripalimab sBLA in esophageus squamous cell carcinoma

Coherus is planning a supplemental BLA for toripalimab after interim Phase 3 results showed it significantly improved OS and PFS in patients with advanced or metastatic esophageal squamous cell carcinoma when added to chemotherapy. Coherus licensed the anti-PD-1 antibody from Shanghai Junshi Biosciences, and are also investigating it in lung, breast, gastrointestinal, genitourinary and skin cancer, as well as soft tissue sarcoma.

Immunocore’s phase 3 in melanoma shows survival benefit

New Phase 3 data from Immunocore comparing tebentafusp with investigator’s choice in treating first-line metastatic uveal melanoma showed the therapy is the first systemic treatment with a survival benefit in the indication. The study showed statistically and clinically meaningful improvement in OS. Tebentafusp, a bispecific using a soluble T cell receptor attached to an anti-CD3 immune effector function, targets gp100, an antigen expressed in melanocytes and melanoma. The results from the randomized, open-label study were published in The New England Journal of Medicine.