On April 3, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported an update to its clinical programs with TIL therapy in the treatment of cervical cancer and non-small cell lung cancer (NSCLC) (Press release, Iovance Biotherapeutics, APR 3, 2019, View Source;p=RssLanding&cat=news&id=2393311 [SID1234534993]). The protocol for innovaTIL-04 (C-145-04), the Phase 2 study in cervical cancer, was amended to increase the sample size to 59 and to modify the primary endpoint of Objective Response Rate (ORR) to be determined by a Blinded Independent Review Committee (BIRC). The company made the changes in anticipation of a meeting with the U.S. Food and Drug Administration (FDA) planned for later this year to discuss the registration pathway for LN-145 in cervical cancer. Earlier this year, LN-145 received a Fast Track designation for cervical cancer.
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"Based on the prior FDA interactions on lifileucel for melanoma, we amended the protocol for the ongoing Phase 2 study of LN-145 in cervical cancer to incorporate certain design elements that we believe are necessary for registration," commented Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "We believe these amendments will help to facilitate the discussion of the registration requirements necessary for this unmet medical need. We look forward to providing an update on the registrational path for LN-145 in cervical cancer later this year."
In addition to the modifications to the cervical study, the company will close the IOV-LUN-201 study in NSCLC and instead plans to add an additional arm to the global IOV-COM-202 study. The new arm will allow for treatment of PD-1/PD-L1 naive NSCLC patients with combination of LN-145 and pembrolizumab. The company anticipates that some of the clinical sites from the IOV-LUN-201 study will be added to the IOV-COM-202 study.
"As the treatment landscape evolves in non-small cell lung cancer, Iovance is adapting its clinical development plan to address the current medical needs," added Dr. Fardis. "Iovance continues to be committed in offering TIL therapy for both early and late line NSCLC through the IOV-COM-202 protocol."
Details on the updates include:
IOV-LUN-201. The Phase 2 trial combining LN-145 and durvalumab for the treatment of patients with non-small cell lung cancer (NSCLC) has been open for approximately a year (NCT 03419559). There are currently eight active sites in the United States seeking patients. No patients have been dosed to date. The treatment landscape for NSCLC has evolved rapidly in the past year. Combination treatment with the PD-1 inhibitor pembrolizumab, with or without chemotherapy, is now approved for use in a first-line setting for metastatic NSCLC and is now standard of care for these patients. Given the advances in the standard of care for these patients, Iovance and AstraZeneca have decided to close the IOV-LUN-201 study.
IOV-COM-202. Iovance remains highly committed to development of LN-145 in NSCLC. The company plans to add some of the existing NSCLC clinical sites and investigators into the IOV-COM-202 trial. IOV-COM-202 is a global study with sites participating from the United States and Europe. As the patient population is expected to be more accessible outside of the United States, this is believed to be a more appropriate location for recruitment of PD-1/PD-L1 naive NSCLC patients.