Jemperli meets PFS endpoint in Phase 3 RUBY endometrial cancer trial

CLINICAL AND REGULATORY

Jemperli meets PFS endpoint in Phase 3 RUBY endometrial cancer trial

The Phase 3 trial compared Jemperli plus standard-of-care chemotherapy followed by Jemperli and chemotherapy plus placebo followed by placebo. GSK said the OS data were immature at the time of this interim analysis, but a favorable trend was observed from the trial. The company expects to submit an sNDA in 1H23. 

Phase 3 data suggest earlier line utility of Pluvicto in prostate cancer

Pluvicto lutetium (177Lu) vipivotide tetraxetan, a PSMA-targeted radioligand therapy from Novartis, showed significant and clinically meaningful benefits in radiographic PFS, the primary endpoint of the Phase 3 PSMAfore trial in patients with PSMA–positive mCRPC. Novartis plans to seek regulatory approval in 2023. If approved, Pluvicto would advance one line of therapy, to treat mCRPC patients before receiving taxane-based chemotherapy.

Arcus’ TIGIT data don’t provide hoped for differentiation

Long-awaited Phase 2 data from Arcus and Gilead’s TIGIT combination answer no questions about whether domvanalimab is differentiated from other therapies in the class, let alone whether it can succeed in Phase 3 given its efficacy appears no better, and may be worse, than Roche’s tiragolumab, which missed in Phase 3. Investors and drug developers had been hoping that data from the Phase 2 ARC-7 trial would provide some hints that prior failures of anti-TIGIT antibodies were related to molecule design rather than the target. They were disappointed, however, as the results provided no clarity in the debate over which Fc engineering strategy is best suited for targeting TIGIT. The data also add to a body of evidence suggesting A2A antagonists do not offer additive efficacy in immunotherapy combinations, at least as measured by ORR and PFS.

AZ’s PD-L1 inhibitor fails against chemotherapy in NSCLC

AstraZeneca disclosed that its PD-L1 inhibitor missed the primary endpoint of overall survival in the   Phase   3   PEARL  study   of  Imfinzi  durvalumab monotherapy vs. platinum-containing chemo in patients with metastatic NSCLC who either have tumors that  express  high  PD-L1 ≥25%,  or who  are determined to be at low risk for early mortality. The study was conducted predominantly in Asia.

European Commission approved Lynparaza in metastatic CRPC

Days after FDA extended the PDUFA for Lynparza olaparib in combination with abiraterone and prednisone or prednisolone to treat mCRPC, the EC has approved the combination for the indication. The approval is based on results from the Phase 3 PROpel trial, where the Lynparza combo reduced the risk of disease progression or death 34% versus abiraterone and prednisone or prednisolone alone. 

Lunsumio is the first bispecific approved for follicular lymphoma

FDA’s approval of Lunsumio mosunetuzumab-axgb from Genentech makes the CD20xCD3 T cell engager the first bispecific approved for relapsed or refractory follicular lymphoma. 

DEALS AND FINANCING

Jazz in tune with Zymeworks’ biliary cancer data, opts in for $325 million

A data readout that could position Zymeworks’ antibody as the first approved HER2-targeted therapy for biliary tract cancers has cemented Jazz’s deal for most of its worldwide rights. Jazz Pharmaceuticals said it will pay $325 million to exercise an option for zanidatamab, a biparatropic antibody targeting two distinct epitopes of HER2, under an October deal with Zymeworks. Jazz opted in two days after Zymeworks said zanidatamab monotherapy led to a 41.3% confirmed ORR among 80 evaluable patients in the pivotal, single-arm Phase 2b HERIZON-BTC-01 trial to treat biliary tract cancer in previously treated patients with HER2-amplified or expressing disease, meaning those with immunohistochemistry scores of 2+ or 3+. The median duration of response was 12.9 months. 

Buoyed by oncolytic virus data, Replimune proposes follow-on

Oncolytic virus company Replimune aims to raise a $125 million follow-on after Phase 1 data were revealed. The company’s engineered herpes virus RP1, also known as vusolimogene oderparepvec, demonstrated an ORR of 36% and a CR rate of 20% in melanoma patients refractory to PD-1 therapy, when administered with Opdivo.