Recent clinical trials and research updates are fueling optimism in the fight against cancer, with several companies reporting significant progress in various oncology areas. Oncolytics Biotech Inc. is leading the charge with its flagship therapy, pelareorep, showing promising results in treating HR+/HER2- advanced or metastatic breast cancer. Incyte Corporation, Regeneron Pharmaceuticals, and others are also contributing with innovative approaches and positive clinical data.
Oncolytics Biotech's Pelareorep Advances Towards Registration-Enabling Study
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is advancing its therapy, pelareorep, toward a pivotal, registration-enabling study, building on the momentum from its BRACELET-1 breast cancer trial. The Phase 2 trial results have generated optimism, with over half of the patients in the pelareorep arm still alive at the study's end. The median overall survival (OS) for patients treated with pelareorep combined with paclitaxel has not yet been reached, with estimates suggesting a 32-month survival benefit compared to just 18 months for the control arm. This outcome, along with a 64% two-year survival rate for the pelareorep group, highlights the therapy's potential to significantly improve patient outcomes.
Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors, noted, "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us. It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy."
These results align with the earlier success of the IND-213 study, which secured FDA Fast Track Designation for pelareorep in 2017. Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, stated, "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer. Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer."
Incyte's CDK2 Inhibitor Shows Promise in Advanced Solid Tumors
Incyte Corporation (NASDAQ: INCY) presented promising results for its CDK2 inhibitor INCB123667 at the ESMO 2024 Congress, showing evidence of clinical activity in patients with advanced solid tumors, notably ovarian cancer. Of the 37 evaluable participants with platinum-resistant ovarian cancer, nine (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]). The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer.
Regeneron Highlights Progress in Oncology Portfolio
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented progress across its oncology portfolio and pipeline at both the ESMO 2024 Congress and IASLC 2024 World Conference on Lung Cancer (WCLC). Regeneron shared five-year survival data on Libtayo (PD-1 inhibitor) first-line monotherapy in advanced non-small cell lung cancer (NSCLC) at IASLC 2024, and longer-term results with investigational fianlimab (LAG-3 inhibitor) plus Libtayo from an initial trial in advanced melanoma showing high clinical activity, including deepening responses.
Israel Lowy, MD, PhD, Clinical Development Unit Head, Oncology, at Regeneron, said, "The breadth of our presentations at ESMO and WCLC underscore our progress in advancing treatment approaches for cancer that have the potential to be among the best in their class. At WCLC, five-year outcomes for Libtayo monotherapy in advanced NSCLC reinforce its position as the anti-PD-1 backbone of our oncology portfolio. At ESMO, the latest two-year data for our LAG-3 inhibitor fianlimab combined with Libtayo show persistent and high clinical activity in advanced melanoma patients."
