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Oncolytics Biotech (NASDAQ:ONCY) shed ~16% on Friday after announcing results from its Phase 2 trial for experimental therapy pelareorep as a combination regimen in patients with a certain type of breast cancer.
Results shared ahead of a presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting indicated a favorable efficacy for pelareorep and chemotherapy paclitaxel, despite safety concerns.
The study, named BRACELET-1, is a partnership between ONCY, Pfizer (PFE), and Merck KGaA (OTCPK:MKGAF) (OTCPK:MKKGY). It involved patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) breast cancer, the most common type of breast cancer.
In BRACELET-1, forty-five patients with HR+/HER2 breast cancer who progressed on at least one hormone therapy were randomized across three groups.
One group received paclitaxel, and the other paclitaxel in combination with pelareorep, while the remaining group received paclitaxel plus pelareorep in combination with Merck KGaA’s (OTCPK:MKGAF) anti-PD-L1 checkpoint inhibitor avelumab (Bavencio).
The company said that the cohort for paclitaxel and pelareorep indicated a ≥50% improvement on the trial’s primary endpoint of overall response rate (ORR) compared to the paclitaxel monotherapy arm at week 16 (31.3% vs. 20%) as of October 2022 data cut.
However, researchers highlighted the need for supportive care, noting that one-third of patients discontinued either pelareorep or avelumab during the trial.
“With these data, our program is phase 3-ready, and efforts to expeditiously advance to a two-arm registrational study of pelareorep-paclitaxel combination therapy are well underway,” CEO of Oncolytics (ONCY) Matt Coffey said. The company plans to share updated results from a May 2023 data cut at an ASCO presentation on June 3, 2023.
