What's Going On With Cancer-Focused Replimune Stock Today?

Replimune Group Inc REPL announced results from the primary analysis of the CERPASS trial evaluating RP1 in combination with cemiplimab for locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). 

The CERPASS study did not meet either of the two primary endpoints of complete response rate (CRR) or overall response rate (ORR). 

RP1, in combination with cemiplimab, increased the CRR versus cemiplimab alone (38.1% vs. 25%, p=0.040), which was just short of the required threshold for statistical significance in this study (p<0.025). 

Among the 83 patients with locally advanced disease, the complete response rate in the RP1 plus cemiplimab group was 48.1% versus 22.6% in the cemiplimab only group. 

The ORR was comparable between the two study groups (52.5% for RP1 plus cemiplimab vs. 51.4% for cemiplimab alone, p=0.692). 

The company notes an imbalance in baseline tumor burden across the treatment groups, which may have impacted the number of responses seen. 

The company also shared initial data from the IGNYTE Cohort of RP1 in anti-PD1 failed melanoma.

In the RP1 plus nivolumab group (n=156), the ORR was 31.4% with a CR rate of 12%, showing activity consistent with the prior snapshot of 91 anti-PD1 failed melanoma patients. 

Biologics license application (BLA) submission is planned for 2H 2024.

The company recently participated in a Type C meeting with the FDA. The agency agreed with an anti-PD1 failed melanoma confirmatory study design concept consisting of a 2-arm randomized trial with the physician's choice of treatment as a comparator arm in the study population. 

As of September 30, 2023, cash and investments total $496.8M. We expect the portfolio's reprioritization will extend the cash runway into early 2026.

Price Action: REPL shares are down 45.20% at $6.75 during the premarket session on the last check Tuesday.