- Design of cervical cancer study amended in anticipation for regulatory interactions -
- Global IOV-COM-202 study to add new combination arm for patients with non-small cell lung cancer; IOV-LUN-201 study to close -
SAN CARLOS, Calif., April 03, 2019 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced an update to its clinical programs with TIL therapy in the treatment of cervical cancer and non-small cell lung cancer (NSCLC). 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.
“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.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to commercialize lifileucel, an autologous cell therapy product using TIL technology that amplifies the body’s own immune response to eradicate solid tumors or attack blood cancers. The company is currently conducting the pivotal study innovaTIL-01 in patients with metastatic melanoma. In addition, the company’s TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including cervical, head and neck, and non-small cell lung cancer. For more information, please visit www.iovance.com.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”). We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. The forward-looking statements include, but are not limited to, risks and uncertainties relating to the success, timing, projected enrollment, manufacturing capabilities, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates (including both Company-sponsored and collaborator-sponsored trials in both the U.S. and Europe), such as statements regarding the timing of initiation and completion of these trials; the timing of and our ability to obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, our product candidates; the strength of Company’s product pipeline; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s manufacturing, license or development agreements; the acceptance by the market of the Company’s product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business, including, without limitation; the preliminary clinical results, including efficacy and safety results, from ongoing Phase 2 studies may not be reflected in the final analyses of these trials, including new cohorts within these trials, and may not be supportive of product approval; the FDA or other regulatory authorities may potentially delay the timing of their approval of, or other action with respect to, the Company’s product candidates; the Company’s ability to address FDA or other regulatory authority requirements relating to its clinical programs and registrational plans, such requirements including, but not limited to, clinical and safety requirements as well as manufacturing and control requirements; risks related to the Company’s accelerated FDA review designations; and the ability of the Company to manufacture its therapies using third party manufacturers. A further list and description of the Company’s risks, uncertainties and other factors can be found in the Company’s most recent Annual Report on Form 10-K and the Company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or www.iovance.com. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
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Iovance Biotherapeutics, Inc.
