Iovance Biotherapeutics Announces Updated Phase 2 Clinical Data from the Lifileucel Metastatic Melanoma Trial at the Society for Immunotherapy of Cancer’s 33rd Annual Meeting
-- 38% Objective Response Rate (ORR) demonstrated in 47 Metastatic Melanoma patients who were unsuccessfully treated with a prior PD-1 blocking antibody -- Median Duration of Response (DOR) of 6.4 Months -- Data selected for oral presentation on Sunday, November 11, 2018
SAN CARLOS, Calif., Nov. 06, 2018 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that a presentation of new data from the ongoing Phase 2 lifileucel metastatic melanoma trial (C-144-01) will occur at the Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting in Washington, D.C. from November 7-11, 2018. Dr. Amod Sarnaik, from H. Lee Moffitt Cancer Center, the lead investigator in the C-144-01 study, will discuss the new data as an oral presentation on Sunday, November 11, 2018. These results will also be presented as a poster beginning November 9, 2018. The company will also host a live webcast of its melanoma program at an event for analysts and investors on Friday, November 9, 2018 from 6:30 – 8:30pm ET during the SITC meeting.
Highlights from the oral and poster presentations include:
-- An ORR of 38% from 47 consecutively dosed metastatic melanoma patients, including one complete response and 17 partial responses, four of which are unconfirmed as of October 25, 2018, pending these patients’ upcoming second assessments -- A median duration of response (DOR) of 6.4 months with a range of 1.3+ to 14+ months -- All patients were unsuccessfully treated with prior anti-PD-1 treatment -- Mean prior systemic therapies for all patients was 3.3
The most common treatment emergent adverse events observed in this cohort to date include chills, febrile neutropenia, anaemia, decreased platelet count, pyrexia, and hypophosphataemia. Two grade 5 events occurred. One was deemed not related to lifileucel by the investigator and the other possibly related.
“The ORR from the ongoing study in post PD-1 metastatic melanoma patients treated with lifileucel continues to be well above the outcomes from the current standard of care for late-stage melanoma patients. In particular, the DOR of greater than six months is very encouraging,” said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. “We are pleased that Dr. Sarnaik can share updated data from the C-144-01 study with the oncology community at SITC.”
As previously reported, an End of Phase 2 meeting with the FDA was held. During this meeting, the FDA acknowledged the potential acceptability of a single-arm cohort for registration. FDA has further acknowledged that conduct of a randomized Phase 3 trial may not be feasible in its intended population of advanced melanoma patients who have been treated with at least one systemic therapy including a PD-1 blocking antibody and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor and is not required for initial registration of lifileucel. Literature suggests that available care for these patients offers approximately 10% ORR. A new cohort of 80-100 patients in C-144-01 will be enrolled with a prospective definition of the primary endpoint of ORR to be read out by a Blinded Independent Review Committee to support registration of lifileucel. This new cohort, which the company refers to as Cohort 4, will be initiated in early 2019 and is expected to be fully enrolled by late 2019/early 2020. BLA submission to FDA is expected in the second half of 2020.
The details of the SITC presentations are as follows:
Concurrent Session 302: Clinical Trials Session, Oral Presentation
Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients following progression on checkpoint inhibitorsAuthor: Amod Sarnaik, MD – H. Lee Moffitt Cancer Center & ResearchPresentation date: Sunday, November 11, 2018Presentation time: 8:10 am ET
Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients following progression on checkpoint inhibitorsAuthor: Amod Sarnaik, MD – H. Lee Moffitt Cancer Center & ResearchDates and times: The poster will be displayed both on Friday, November 9, 2018 from 8 a.m. – 8 p.m. ET and Saturday, November 10, 2018 8:00 a.m. – 8:30 pm ET.Location: Hall EPoster number: 022Presentation: Dr. Sarnaik will moderate the poster presentation on Saturday, November 10, 2018 from 12:20 pm – 1:50 pm and 7:00 pm – 8:30 pm, local time
About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. (the Company) is a clinical-stage biotechnology company focused on the development of cancer immunotherapy products for the treatment of various cancers. The Company’s lead product candidate is an adoptive cell therapy using TIL technology being investigated for the treatment of patients with metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck, recurrent, metastatic or persistent cervical cancer and locally advanced or metastatic non-small cell lung cancer. For more information, please visit http://www.iovance.com.
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