NewLink Genetics Launches Adaptive Design Phase 2B/3 Clinical Trial of tergenpumatucel-L Immunotherapy in Patients with Non-Small Cell Lung Cancer
The Phase 2B portion of the study will evaluate two dosing schedules for tergenpumatucel-L versus docetaxel and the Phase 3 portion of the study will further assess efficacy of the selected dose against docetaxel. The primary endpoint of the study will be to evaluate survival in second-line therapy for patients with advanced non-small cell (stage IIIB/IV) lung cancer. Secondary objectives include progression free survival, evaluation of tumor response, and immunological response in treated patients.
"We are pleased to move another promising HyperAcute product candidate with encouraging survival data from Phase 2 into advanced-stage studies," commented Dr.
"Immunotherapies are emerging as one of the most promising next treatment paradigms for cancer patients by allowing the patient's immune system to fight their disease without significant new toxicities. We are excited to participate in this advanced study to evaluate NewLink's innovative HyperAcute Lung immunotherapy in NSCLC," said principal investigator of the study Dr.
"This trial design is based on Phase 2 non-small cell lung cancer data presented at the recent ASCO meeting demonstrating 11.2 months median survival in 2nd and 3rd line patients who failed prior treatment. Our correlative immunological data showing 21.9 vs. 7 months survival in certain patients capable of generating IFN-gamma responses versus patients who did not mount this response, suggest patients with the best immune responses may have significantly greater long term overall survival. If these types of data can be confirmed in the new larger, randomized study an important novel therapy will be made available for patients with very limited options. We are delighted to be one of the lead centers," commented principal investigator for the Phase -2 study and Co-PI for the Phase 3 study Dr.
Although a number of therapies have been approved in lung cancer, the prognoses for patients remain poor. "This study is designed to test the hypothesis that patients treated with HyperAcute immunotherapies may be sensitized to subsequent treatments with chemotherapy while also evaluating whether survival benefits observed in our Phase 2 study can be reproduced in a large controlled Phase 3 study," commented Dr.
Adaptive Study Design
This Phase 2B/3 study will enroll patients having a better baseline immune system status relative to the patient population in the earlier Phase 2 study. In order to be eligible for the study, patients must have Stage IIIB or Stage IV recurrent or treatment refractory non-small cell lung cancer with good performance status (ECOG < 2) and no more than one prior chemotherapy failure. A lymphocyte count of > /= 1000/μL, platelets > /= 100,000/μL, hemoglobin > 10.0 gm/dL, albumin > /= 3.0 gm/dL and acceptable hepatic and renal function are required for enrollment.
Two hundred forty (240) patients will be randomized (2:1:1) to receive: Arm 1: Docetaxel 75 mg/m2 intravenously given every 3 weeks for 4 doses; Arm 2a: Tergenpumatucel-L at 300 million cells given by intradermal injection weekly for 11 weeks then every 2 months for 5 additional doses (up to a total of 16 immunizations); Arm 2b: Tergenpumatucel-L at 300 million cells given by intradermal injection every 2 weeks for 6 doses and then every month for 10 additional doses (up to a total of 16 immunizations).
Phase 3 Study Design
In the phase 3 portion of the study, patients will be randomized (1:1) to receive either docetaxel or tergenpumatucel-L at the dose level that was selected in the Phase 2B portion of the study. At the planned interim analysis a sample size re-estimation will be performed that will determine the final enrollment numbers for the trial.
About Non-Small Cell Lung Cancer
According to the
About tergenpumatucel-L
The HyperAcute-Lung Immunotherapy product candidate, tergenpumatucel-L, consists of three separate allogeneic lung tumor cell lines grown in large cultures, harvested, packaged and irradiated. These component cells are representative of the three major types of non-small cell lung cancer and have been engineered to express a foreign gene encoding the alpha-galactosyl transferase enzyme. This enzyme modifies the surface of the cells in tergenpumatucel-L to make them more easily recognized and attacked by the immune system. After vaccination with tergenpumatucel-L, some patients' immune systems respond by recognizing new lung cancer antigens in ways thought to be helpful in fighting their own tumor.
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Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of1995. These statements include, but are not limited to, statements regarding the prospects of tergenpumatucel-L and the prospects of NewLink's Phase 2B/3 clinical trial. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with clinical trials and the regulatory approval process. These and other factors are identified and described in more detail in the Company's filings with the
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