On November 6, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported 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) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C. from November 7-11, 2018 (Press release, Iovance Biotherapeutics, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375545 [SID1234530754]). 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 (Free SITC Whitepaper) meeting.

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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 (Free SITC Whitepaper)."

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 (Free SITC Whitepaper) 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 inhibitors
Author: Amod Sarnaik, MD – H. Lee Moffitt Cancer Center & Research
Presentation date: Sunday, November 11, 2018
Presentation time: 8:10 am ET

Poster Presentation

Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients following progression on checkpoint inhibitors
Author: Amod Sarnaik, MD – H. Lee Moffitt Cancer Center & Research
Dates 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 E
Poster number: 022
Presentation: 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