Merck announced Phase 3 trial met OS endpoint as first-line treatment of HER2+ gastric cancer

CLINICAL AND REGULATORY 

Merck announced Phase 3 trial met OS endpoint as first-line treatment of HER2+ gastric cancer 

Based on results from KEYNOTE-811, Keytruda is approved in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved by FDA under accelerated approval regulations based on the ORR and durability of response demonstrated at an earlier analysis. Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study. In the final analysis of this trial, Keytruda in combination with trastuzumab and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo in combination with trastuzumab and chemotherapy in the intention-to-treat study population, with the greatest benefit observed in patients whose tumors expressed PD-L1 (CPS ≥1). The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide. 

Merck discontinues its TIGIT combination with Keytruda 

Merck & Co. announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial evaluates the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and Keytruda compared to Keytruda alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV). At a pre-planned analysis, data showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria. A higher rate of discontinuation of all adjuvant therapy by patients in the coformulation arm versus the Keytruda-only arm, primarily due to immune-mediated adverse experiences, rendered it highly unlikely that the trial could achieve a statistically significant improvement in RFS. Based on the recommendation of an independent Data Monitoring Committee (DMC), Merck is unblinding the study and recommends that patients receiving the vibostolimab and pembrolizumab coformulation be offered the option to be treated with Keytruda monotherapy. Data analysis from this study is ongoing. Results will be shared with the scientific community and communicated to regulatory agencies. 

DEALS AND FINANCING 

iTeos Therapeutics annoucned $120 million registered direct offering 

iTeos Therapeutics has entered into a securities purchase agreement to sell 1,142,857 shares of its common stock at a price of $17.50 per share and pre-funded warrants to purchase up to 5,714,285 shares of the common stock at a price of $17.499 per pre-funded warrant, in a registered direct offering. The aggregate gross proceeds from the offering are approximately $120 million. The financing is being led by existing investors, RA Capital Management and Boxer Capital. iTeos expects to use net proceeds from the financing to advance its clinical programs and preclinical pipeline, and for working capital and other general corporate purposes. 

Context Therapeutics announced $100 million private placement 

Context Therapeutics has entered into a securities purchase agreement with certain new and existing investors in a private placement that resulted in gross proceeds of approximately $100 million. The private placement is led by new investor Nextech, with participation from new and existing investors, including Ally Bridge Group, Avidity Partners, Blackstone Multi-Asset Investing, Blue Owl Healthcare Opportunities, Deep Track Capital, Driehaus Capital Management, Great Point Partners, and other leading healthcare investors. Context expects that the net proceeds from the private placement will extend its cash runway through the estimated duration of the Company’s planned CTIM-76 Phase 1 clinical trial, as well as into 2028. Piper Sandler was acting as sole placement agent for the private placement.