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Replimune shares halve as skin cancer drug fails to CERPASS phase 2

2023-12-05

临床结果临床3期临床2期

Replimune blamed an imbalance in baseline tumor burden in the treatment groups, which may have impacted the responses.

Replimune’s RP1 is an “active agent” accortumorto CEO Philip Astley-Sparke, but it didn’t achieve the primary endpoints of complete response or overall response in a phase 2 trial of patients with a type of skin cancer.

Replimunech’RP1hares halved as the markets opened Tuesday, from $11.95 at open to $6.13. Despite the bleak update for the cutaneous squamous cell carcinoma (CSCC) trial called CERPASS, in a broad clinical upskin cancery, Replimune pointed to success in a separate melanoma study that could lead to a regulatory filing.

On the CSCC front, RP1 was being tested in 211 patients with locally advanced or metastatic CSCC, randomized to receive eicutaneous squamous cell carcinoma (CSCC)tayo standard of care. The trial did not meet either primary endpoints assessing the complete responsemelanoma overall response rate.

The comCSCCchieved RP1omplete response rate of 38.1% compared to 25% for the standard-of-care group, which was just shy of the RP1esholdRegeneronistLibtayognifLibtayo The p-value was 0.025. Replimune singled out patients with locally advanced disease, who had a slightly higher response rate of 48.1% for the RP1 group compared to 22.6% for standard of care. The overall response rate was comparable in the two groups, at 52.5% and 51.4%, respectively.

Replimune also flagged that the RP1 group seemed to have a higher duration of response compared to Libtayo alone, but the data is not yet mature and needs further follow-up.locally advanced disease

Replimune RP1 plus cemiplimab provided particularly meaningful clinical activity for many patients Libtayofficult-to-treat, disfiguring tumors that typically have the greatest impact on quality of life, given their size and location,” the company said.

Replimune RP1med ancemiplimab in baseline tumor burden in the treatment groups, which may have impacted the responses. A greater number tumorsients who had larger tumors, measured at 10 cm or more, ended up in the RP1 group, the company said.

The trial will go on to assess the duratiotumorresponse, progression-free survival and overall survival.tumors

On safety, Replimune reported mostly grade 1 and 2 flu-like symptoms, “a range” of grade 3 events in one patient in each group and one grade 4 instance of immune-mediated myocarditis and myocarditis in each arm of the trial. There were no deaths reported.

Replimune also unveiled initial data from a group oflu-like symptomsnti-PD1 failed melanoma from the phase 1/2 program called IGNYTE. The therapy was testeimmune-mediated myocarditisregismyocarditisohort, but Replimune also presented data today on a group of 16 patients from an earlier cohort in the indication.

Replimunetaking RP1 and Bristol Myers Squibb’s Opdivo had an overall resPD1 failed melanoma PD1se rate of 31.4% and a complete response rate of 12%, which is consistent with a prior “snapshot” of 91 patients from the trial, RepliReplimune. About half of the patients experienced clinical benefit: either complete response, partial response or stable disease. All of the patients have ongoing responses at six months, and 78% have responses ongoing as of Nov. 6. Replimune expects a primary analysis from the study once all patients achieve 12 months of treatment, which should occur around March 2024.

Again, ReplimuneRP1porteBristol Myers SquibbandOpdivoatment-related adverse events, with flu-like symptoms the most common. The company said there was “a low incidence of Grade 3-5 events”—a grade 5 meaniReplimuneent death. There were four grade 4s reported, which signifies a life-threatening condition or one requiring urgent intervention. Replimune said there was a case each of increased lipase, cytokine release syndrome, myocarditis andReplimunecytosis.

The deaReplimunecase of myocarditis that Replimune said was attributed to Opdivo, for whiflu-like symptomscomplication.Replimune cytokine release syndrome myocarditis

Replimune recently met wmyocarditis for a type C meeting, where the companOpdivothe agency’s blessing for the design of a confirmatory study in anti-PD1 failed melanoma. Replimune will conduct a two-arm randomized trial with a physician’s choice treatment as a comparator. The phase 3 trial should be underway by the time the company submits an application for accelerated approval in this population. A full biologics license application should be submitted once the patients have been followed for 12 months, around the second half of 2024.

Replimunethis going on, Replimune has decided to trim its pipeline to focus on the confirmatory trial for anti-PD1 failed melanoma and a registrationPD1 failed melanoma PD1study for RP2 in uReplimunenoma. Development of RP2 and RP3 in squamous cell carcinoma of the head and neck and colorectal cancer will be discontinued, Replimune said. RP2 will continue in second-line hepatocellular carcinoma, while RP3 will be discontinued entirely.

Replimune has $496.8 milReplimuneash on hand as of Sept. 30, which should last the company into early 2026.PD1 failed melanoma PD1 uveal melanoma RP2 RP3 squamous cell carcinoma of the head and neck colorectal cancer Replimune RP2 hepatocellular carcinoma RP3