Immunotherapy Drug Pairings Revitalizing the Fight Against Cancer

November 05, 2019 -

Within a global market that’s projected to grow at a rate of 12.3% CAGR to hit US$196.2 billion by 2026, there are several encouraging improvements on the way in the oncology drug market, thanks to new pairings and studies. Among the current developments are innovations coming from developers such as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) and Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) and Nektar Therapeutics (NASDAQ:NKTR), as well as majors such as Bristol-Myers Squibb (NYSE:BMY), l Novartis AG (NYSE:NVS), and Eli Lilly and Company (NYSE:LLY).

Together many of these smaller cap developers are introducing potential options for pairings with the already-approved drugs of the majors. One encouraging example is the combination study between pelareorep from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) with nivolumab (Opdivo®) from Bristol-Myers Squibb (NYSE:BMY).

Already ranking as one of the top grossing oncology drugs, sales of Opdivo in 2018 were US$6.7 billion. Survival data from four studies in April showed 14% of all Opdivo-treated patients were alive at four years.

The combination study began in December, with a proteasome inhibitor for patients with relapsed/refractory multiple myeloma. The study expands on Oncolytics’ strategy of investigating the importance of systemic pelareorep administration followed by checkpoint blockade.

This combination study will not only help demonstrate the specific role of pelareorep in promoting an inflamed phenotype, it should also help demonstrate how the virus can promote responses to checkpoint blockade in cold tumors.

“Having worked with pelareorep in multiple myeloma and understanding its ability to act as a potentiator of checkpoint blockade, I’m very excited to work with the Oncolytics team on this study,” said Dr. Craig Hofmeister, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine. “Pelareorep has proven its ability to create an inflamed phenotype and its potential for upregulation of PD-1 on tumor-infiltrating lymphocytes. My hope is this study leads not only to an effective combination dosing schedule but provides quantitative data describing the expression of PD-1, along with correlative studies that reveal the roles of both immune-mediated and direct cytotoxic myeloma cell killing.”


The hope for Oncolytics’ pelareorep is to make steady progress not unlike what bempegaldesleukin (NKTR-214) from Nektar Therapeutics (NASDAQ:NKTR) achieved when combined with Opdivo—when it received US FDA Breakthrough Therapy Designation in the combination.

Pelareorep is an immuno-oncology virus for the treatment of cancer, both solid and in malignancy. Once entered into the bloodstream, the virus specifically targets and enters cancer cells, where it replicates itself and triggers an attack response from the body’s immune system.

Since its development, Oncolytics Biotech has been working on studies to discover pelareorep’s efficacy when partnered with not only Opdivo for lung cancer, but also to fight breast cancer with other major approved cancer drugs, such as Bavencio from Pfizer Inc. (NYSE:PFE), Keytruda from Merck & Co. (NYSE:MRK), and Tecentriq from Roche Holding AG(OTC:RHHBY).

Dr. Hofmeister’s open-label, phase 1 study is being conducted at Emory University, will enroll up to 62 patients to examine the side effects and best dosing schedule of pelareorep when given in combination with dexamethasone, carfilzomib, and nivolumab in treating participants with relapsed multiple myeloma.

“We now have our second checkpoint inhibitor combination study enrolling, and I’m excited for the potential of the immune and biomarker data to come from it,” said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. “These studies, along with our soon to be initiated studies combining pelareorep with Merck’s Keytruda, also in multiple myeloma, and Roche’s Tecentriq in neoadjuvant breast cancer, will provide further evidence that pelareorep has the potential to expand the use of checkpoint inhibitors by priming tumors cells. The confirmation of our predictive biomarkers enhances the likelihood of success in registrational studies, thereby reducing both clinical and commercial risk making pelareorep more attractive to potential partners.”

Known as checkpoint blockade immunotherapy (or immune checkpoint inhibitors), the segment is the fastest growing segment of immuno-oncology. As a segment of the entire oncology drug market, immune checkpoint inhibitors alone are projected to reach more than US$56.5 billion by 2025, growing at an explosive CAGR of 20.1%.


Ahead of October’s Breast Cancer Awareness Month campaigns, Novartis AG (NYSE:NVS) announced it had delivered on consistently superior overall survival from its MONALEES-3 Kisqali trial, demonstrating more life for postmenopausal HR+/HER2- advanced breast cancer patients. As per the results announcement, Kisqali is the only CDK4/6 inhibitor to demonstrate positive overall survival in two pivotal Phase III trials—consistently demonstrating approximately 30% reduction in the risk of death.

Just a couple weeks later, Eli Lilly and Company (NYSE:LLY) announced the results of its MONARCH 2 study, showing that its drug Verzenio (abemaciclib) significantly extends life by a median of 9.4 months for women with HR+, HER2-advanced breast cancer. The results showed Verzenio extended life, moving previously treated with endocrine therapy (median of 46.7 months vs median of 37.3 months with placebo plus fulvestrant).

Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) recently announced the acceptance of an abstract highlighting data from an AWARE-1 study to be presented at the Society for Immunotherapy of Cancer (SITC) annual meeting to be held in November 6-10, 2019.

The abstract, A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1), was authored by AWARE-1 principal investigator, Aleix Prat, et al. Dr. Prat is Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics' Scientific Advisory Board.

Learn more about Oncolytics Biotech Inc. here:

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USA News Group


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