On November 21, 2021 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported updated interim data from the Phase 1 data from RP2 alone and in combination with Opdivo that continues to provide strong support for the next stage development of RP2 (Press release, Replimune, NOV 12, 2021, View Source [SID1234595407]). The poster will be presented November 12-14, 2021 at 7:00 a.m. ET to 5:00 p.m. ET at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held November 10-14, 2021.
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Updated RP2 data shows compelling durability of response as single agent and in combination with Opdivo providing additional evidence of the clinical utility of RP2 in patients with hard-to-treat, anti-PD1 failed cancers.
RP2 leverages Replimune’s platform to express an anti-CTLA-4 antibody, in addition to GALV-GP R- and GM-CSF which is expressed by RP1. The Company has now fully enrolled the 30-patient cohort evaluating RP2 combined with Opdivo following previously completing enrolment of the 9-patient cohort evaluating RP2 as monotherapy. The Phase 1 clinical trial population comprised patients with advanced cancers having failed, or being ineligible for, standard of care options.
The updated interim data shows:
In the nine-patient monotherapy cohort with RP2, two of the initial three patients who achieved response remain in response, these being a patient with esophageal cancer (partial response; previously anti-PDL1 failed) at 22 months from entering the trial and a patient with mucoepidermoid carcinoma (complete response) at 19 months from entering the trial. As previously reported, the third responding patient with uveal melanoma with a partial response (Yervoy/Opdivo failed) progressed at 15 months from entering the trial.
Updated data from the 30-patient cohort of RP2 in combination with Opdivo shows durable responses ongoing at out to >425 days.
To date, seven of the 30 patient (23.3%) cohort of RP2 in combination with Opdivo have achieved partial responses, with additional patients still on study with the opportunity to achieve a response. Six of the seven responses are ongoing with depth of response having been maintained or deepened over time.
The responding patients are four of nine patients with cutaneous melanoma (all anti-PD1 or anti-PD1 and anti-CTLA-4 failed), two of eight patients with uveal melanoma (anti-PD1 or anti-PD1 and anti-CTLA-4 failed) and one of three patients with squamous cell carcinoma of the head and neck (anti-PD1 failed).
Biomarker data continues to demonstrate substantial increases CD8 T cells and PD-L1 expression, with T cell receptor sequencing and Nanostring expression analysis further indicating potent and broad activation of an anti-tumor immune response.
No correlation has been observed between the degree of anti-tumor response and the baseline levels of PD-L1 expression, in line with the intended mechanism of action for RP2 of turning immunologically ‘cold’ tumors ‘hot’.
Overall the data, including the durability of the responses, continues to support that oncolytic immunotherapy-mediated expression of anti-CTLA-4 from RP2 provides potent & systemic anti-tumor effects, without substantial additional toxicity as compared to the oncolytic backbone (RP1), including without evidence of the side effects associated with systemic ipilimumab.
Based on the observation of durable clinical responses in patients with liver metastases following treatment with both RP1 and RP2, the Company has amended the clinical trial protocol to enrol an additional 24 patients with liver metastases from lung cancer, gastrointestinal cancers, breast cancer and uveal melanoma.
Replimune will also be presenting three additional Trial in Progress presentations at this year’s SITC (Free SITC Whitepaper) Annual Meeting
Abstract Title: ARTACUS: An open-label, multicenter, phase 1b/2 study of RP1 in solid organ transplant recipients with advanced cutaneous malignancies (Trial in Progress presentation)
Abstract Number: 550
Session Date and Time: November 12-14, 2021 from 7:00 AM ET- 5:00 PM ET
Location: Hall E
Abstract Title: CERPASS: A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (Trial in Progress presentation)
Abstract Number: 547
Session Date and Time: November 12-14, 2021 from 7:00 AM ET- 5:00 PM ET
Location: Hall E
Abstract Title: IGNYTE: An open-label, multicenter, phase 1/2 (Ph 1/2) clinical trial of RP1 ± nivolumab in patients with advanced solid tumors (Trial in Progress presentation)
Abstract Number: 506
Session Date and Time: November 12-14, 2021 from 7:00 AM ET- 5:00 PM ET
Location: Hall E
The full posters will be posted to the presentations section of the Replimune website at View Source