Oncolytics Biotech is getting ready for a registrational Phase III clinical trial after announcing positive results from a Phase II trial investigating a combination therapy in HR+/HER2- breast cancer.

President and CEO Dr Matt Coffey said that with the recent data, the company is ready for a two-arm Phase III trial which will investigate pelareorep in combination with chemotherapy paclitaxel. The Canada-based company did not disclose the estimated trial initiation date.

In the Phase II trial, pelareorep was evaluated in combination with paclitaxel, in combination with chemotherapy and Merck’s Bavencio (avelumab) and compared to paclitaxel alone.

The data analysis showed that the overall response rate (ORR) at week 16 in the combination therapy of pelareorep and paclitaxel cohort was 31.1%. In the chemotherapy cohort ORR was 20%, while in the three-drug combination arm ORR was 17.6%. ORR was the trial’s primary endpoint.

The median progression-free survival (PFS) in the duo-combination therapy cohort was 9.6 months, 7.5 months in the trio-combination arm and 6.4 months in the chemotherapy arm. The cut-off date for this data analysis was October 2022.

Oncolytics notes that overall survival (OS), one of the trial’s secondary endpoints, data is still maturing. Updated results as of the May cut-off date will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in June.

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As for biomarker data, a statistically significant increase in T cell fraction was observed in the duo-combination cohort but not in the trio-combination arm. Pelareorep, an intravenously delivered immunotherapeutic agent, displayed an acceptable safety profile which is consistent with what has been observed in previous studies.

The open-label Phase II trial (NCT04215146) enrolled 48 patients with HR+/HER2- endocrine-refractory metastatic breast cancer. The trial evenly randomised 45 patients into three cohorts to receive either chemotherapy, pelareorep and chemotherapy or pelareorep with Bavencio and chemotherapy.

Breast cancer landscape

Breast cancer screening by mammography is the leading method of early disease detection and can reduce mortality by up to 40%.

However, a recent report by GlobalData epidemiologists indicates that high breast density can be a barrier to effective mammography. The high density can produce false positives or obscure small tumours. According to the US Centers for Disease Control and Prevention (CDC), breast density is determined by the ratio of fibrous tissue, glandular tissue, and fatty tissue in breasts.

The epidemiologists also predict that there will be over 278,000 diagnosed cases of invasive breast cancer in 2023. Clinical Trials Arena previously reported on how breast cancer trial participants are getting younger. This poses questions on how to accommodate younger participants to protect their fertility.