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Replimune® Replimune Provides Data Update from its RP1 ( vusolimogene oderparepvec ) and RP2 Programs and Announces Plans to Expand the Development of RP2 / 3 Beyond Phase 1 June 3 , 2021 High rate of complete responses in RP1 skin cancer cohorts underscore the potential for profound patient benefit and supports the ongoing registration directed development programs RP2 data confirms the signal with RP1 in anti - PD1 failed melanoma , uveal melanoma and in treating patients whose cancer has metastasized to the liver Announces plans to initiate broad Phase 2 development of RP2 and / or RP3 in tumor types that commonly metastasize to the liver Virtual investor event to be held at 8:00 am ET WOBURN , Mass . , June 03 , 2021 ( GLOBE NEWSWIRE ) -- Replimune Group , Inc. ( NASDAQ : REPL ) , a biotechnology company developing oncolytic immuno - gene therapies derived from its ImmulyticⓇ platform , today announced updated interim data from the Phase 2 skin cancer cohorts combining RP1 ( vusolimogene oderparepvec ) with OpdivoⓇ * ( nivolumab ) and data from RP2 alone and in combination with Opdivo that continues to provide strong support for development in its lead indications . Additionally , Replimune announced plans to initiate a Phase 2 clinical trial program in tumor types that metastasize to the liver . A virtual investor event will be held today at 8:00 a.m. ET to discuss the updated data . " As our data matures there are some clear themes emerging , " said Philip Astley - Sparke CEO of Replimune . " In our longest - running clinical trial of RP1 combined with Opdivo in melanoma and in non - melanoma skin cancers including cutaneous squamous cell carcinoma ( CSCC ) , we are seeing a clear trend that partial responses tend to convert to complete responses over time , providing many patients with the potential for a cure while also having a transformative long - term impact on quality of life . Our updated data further support our two registration - directed studies in skin cancers . We look forward to seeing if we can replicate the data we have seen with RP1 in skin cancers in anti - PD1 / L1 failed non - small cell lung cancer ( NSCLC ) , where we recently dosed our first patient . The signal with RP1 in patients who have failed anti - PD1 is continuing with RP2 and reinforces the potential utility of our platform for treating patients who have failed prior immune checkpoint therapy . Finally , the signal with RP1 indicating the potential to treat patients with liver metastases , who in general have a very poor prognosis , has been further confirmed with RP2 , where we are now planning to move into Phase 2 development with RP2 / 3 in tumor types that commonly metastasize to the liver , including colon cancer , lung cancer and breast cancer . " Updated clinical data from the Phase 2 cohort with RP1 in combination with Opdivo in patients with CSCC and other non - melanoma skin cancers continues to support the CERPASS registration - directed clinical trial of RP1 in combination with Libtayo® * ( cemiplimab ) in CSCC The data continues to demonstrate that RP1 in combination with Opdivo is well tolerated and that it drives deep and durable responses in patients with CSCC with the number of complete responses ( CRs ) , a dual independent primary endpoint in the CERPASS study , continuing to increase . At the current data cut off ( n = 15 ) , seven of the nine responses are complete responses with a current CR rate of 46 % and overall response rate ( ORR ) of 60 % . Another potentially eighth complete response will require biopsy confirmation . The Company believes this data provides clear differentiation versus anti - PD1 therapy alone and provides strong validation of Replimune's current registration - directed clinical development plan , with the initial readout of the CERPASS study expected in 2022 . Updated clinical data evaluating RP1 in combination with Opdivo in anti - PD1 failed melanoma patients continues to strongly support the Company's registration - directed cohort in the IGNYTE clinical trial Sixteen anti - PD1 failed cutaneous melanoma patients were enrolled into the previously reported 30 patient cohort in melanoma ( which included anti - PD1 naïve cutaneous melanoma , mucosal and uveal melanoma , in addition to anti - PD1 failed cutaneous melanoma ) . The status of the anti - PD1 failed melanoma patients is as follows : • Five of these patients have so far met the formal criteria for response ; four of which had previously failed both anti - PD1 and anti - CTLA - 4 therapies , with a current ORR of 31 % . • Of two further patients on study one remains a surgical complete response at 18 months from the start of treatment ( classified as stable disease according to the study protocol ) and the second patient with local progression following an extended period of stable disease has reinitiated RP1 treatment and is responding to therapy . Despite improvements in therapy , many melanoma patients treated with anti - PD1 therapy have primary resistance or acquire resistance to immune checkpoint blockade following initial response . The clear activity of RP1 in combination with Opdivo in anti - PD1 failed patients , including in patients with extensive visceral disease , represents a new potential therapeutic option for these patients . Based on the initial data with RP1 in melanoma , the Company initiated a registration - directed 125 - patient cohort of anti - PD1 failed melanoma which is expected to read out in 2022. The signal with RP1 in anti - PD1 failed melanoma indicating that the Replimune series of product candidates may provide an effective therapy for these patients has also been further confirmed with RP2 ( see below ) , although there are no current plans to independently develop RP2 in cutaneous melanoma .