- OncoSec Medical Incorporated (NASDAQ:ONCS) shares plummeted Monday following Phase 2 KEYNOTE-695 clinical trial data. The primary endpoint of the overall response rate (ORR) was not met.
- The company evaluated TAVO-EP, in combination with Merck & Co Inc (NYSE:MRK) Keytruda (pembrolizumab) in unresectable or metastatic (Stage III/IV) melanoma.
- The patients in the trial had confirmed disease progression after at least 12 weeks exposure to immediate prior anti-PD-1 antibody therapy (pembrolizumab or nivolumab).
- Among 98 efficacy evaluable patients, the confirmed ORR was 10.2% which did not achieve the pre-specified clinically meaningful ORR of ≥17%.
- Related: OncoSec Touts Encouraging Early Data For Opdivo Combined Immunotherapy For Skin Cancer.
- The BICR results for 98 efficacy evaluable patients are lower than the ORR per RECIST v1.1 by investigator assessment of 18.8% for the 101 patients previously reported as the key secondary endpoint of the KEYNOTE–695 trial.
- As previously reported, the median overall survival for all enrolled 105 patients was 22.7 months after a median follow-up period of 33.4 months.
- The company plans to pursue TAVO-EP in combination with anti-PD-1 therapy in the neoadjuvant melanoma setting.
- A meeting with the FDA to discuss a phase 2 randomized trial in the melanoma neoadjuvant setting is scheduled for May 2023, and potentially initiate the Phase 2 study in 2H of 2023.
- Price Action: ONCS shares are down 50.4% at $1.28 on the last check Monday.
S&P 500 Down Over 1% Ahead Of Fed Minutes; Market Volatility Increases
The S&P 500 dropped over 1% on Tuesday amid concerns over progress in U.S. debt ceiling talks.
The representatives of President Joe Biden and Republican lawmakers concluded another round of negotiations on Tuesday with no signs of progress.
