On Monday, Merck & Co Inc (NYSE:MRK) announced topline data from the Phase 3 KEYLYNK-001 trial.
The trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza (olaparib), with or without bevacizumab, as a first-line treatment for BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival.
At the final analysis conducted by an independent Data Monitoring Committee, the Keytruda plus Lynparza regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival for these patients compared to chemotherapy alone.
The study did not reach its secondary endpoint of overall survival. The role of keytruda in the intention-to-treat population remains uncertain at this time.
In the U.S., Lynparza has three approved indications in ovarian cancer. Keytruda is not approved to treat ovarian cancer.
Sunday, Merck announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone plus rituximab (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL).
At a pre-planned analysis, zilovertamab vedotin in combination with R-CHP achieved a 100% (n=15) complete response (CR) rate in patients treated with zilovertamab vedotin at 1.75 mg/kg.
Based on the data, the study has established 1.75 mg/kg as the recommended Phase 3 dose of zilovertamab vedotin.
The efficacy results showed a complete response was achieved in combination with R-CHP in 100% (n=15) of patients receiving the 1.75 mg/kg dose of zilovertamab vedotin, 93.3% (n=14) of patients receiving the 2.0 mg/kg dose, and 100% (n=6) of patients receiving the 2.25 mg/kg dose.
The total complete response rate at the end of treatment was 97.2%. The median follow-up for all patients was 17.6 months.
The objective response rate was 100% for patients receiving the 1.75 mg/kg dose, 93.3% for patients receiving the 2.0 mg/kg dose, and 100% for patients receiving the 2.25 mg/kg dose, all combined with R-CHP.
The median duration of response has not been reached for all patients, and the total 12-month duration of response was 93.5%.
Based on the data, the recommended zilovertamab vedotin dose was determined to be 1.75 mg/kg.
Price Action: MRK stock is up 0.99% at $104.11 at last check Monday.
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