Replimune Group, Inc. (REPL) shares are climbing Monday as the company unveils final data from its Phase 1 study of RP2, an oncolytic immunotherapy, at the American Society of Clinical Oncology (ASCO) annual meeting. The stock was up 7.02% in premarket trading at $9.295.
The Phase 1 study tested RP2 both alone and in combination with Bristol-Myers Squibb's (BMY) Opdivo (nivolumab) in 85 heavily pretreated patients with advanced solid tumors. These are patients who have run out of standard options, so any response is noteworthy.
RP2 monotherapy delivered an objective response rate (ORR) of 19.0% (4 out of 21 evaluable patients). The combination with nivolumab matched that with a 19.1% ORR and a disease control rate of 48.9%. The median duration of response wasn't reached in the monotherapy group, meaning many responders were still benefiting when data was cut, while the combination group saw a median duration of 22.1 months.
Importantly, tumor regression was observed in both injected and non-injected lesions, including in all three monotherapy responders who had non-injected lesions. That suggests the therapy is triggering a systemic immune response, not just a local one — a key goal for cancer immunotherapies.
On Saturday, Replimune also presented three-year landmark overall survival data from the IGNYTE clinical trial of RP1 (vusolimogene oderparepvec) plus nivolumab for anti-PD-1 failed melanoma. These are patients whose cancers stopped responding to checkpoint inhibitors, a tough population.
The combination achieved a median overall survival of 32.9 months. At three years, 47.8% of all treated patients were still alive, and that number jumped to 83.5% among responders. The ORR was 33.6%, with a median duration of response of 24.8 months, and 44.8% of responders maintained their response at three years.
Replimune's momentum score on MarketDash's Edge platform is weak at 27.02, indicating the stock has been underperforming the broader market despite today's pop. The verdict: it's a momentum-driven story with challenges in sustaining upward price action. Investors should keep an eye on upcoming presentations and earnings to gauge whether the clinical data can translate into long-term value.
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