Biotech Innovations Address Over 2 Million New Cancer Cases Projected for 2024

In 2024, the USA anticipates surpassing 2 million new cancer cases, marking a significant milestone in the battle against this pervasive disease. In response to the escalating cancer rates, the National Cancer Institute advocates for a transformation in cancer clinical research methodologies, emphasizing the urgency for patients. The Global Oncology Drugs Market is forecasted to expand at a compound annual growth rate (CAGR) of 11.5% through 2033, potentially reaching $564.5 billion, underlining the escalating demand for advanced therapies and the need for incentives for their development.

Among the companies at the forefront of addressing these needs are Oncolytics Biotech Inc., GSK plc, Guardant Health, Inc., Exelixis, Inc., and Gilead Sciences, Inc. These firms are making notable strides in oncology, developing innovative therapies to meet the growing demand.

Oncolytics Biotech Inc., a clinical-stage company dedicated to oncology immunotherapy, has revealed promising progress. The company announced productive feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding its HR+/HER2- metastatic breast cancer (mBC) program. The FDA has expressed support for a registration-enabling trial for pelareorep, with progression-free survival as the primary endpoint and overall survival as a critical secondary endpoint. This trial will target patients who have failed hormonal therapy and have had no more than one line of antibody-drug conjugate (ADC) therapy.

Thomas Heineman, Chief Medical Officer at Oncolytics, highlighted the significance of the FDA's alignment on the trial's design, building on data from previous studies such as BRACELET-1 and IND-213. These studies demonstrated significant benefits for patients treated with pelareorep and paclitaxel compared to those receiving paclitaxel alone. Heineman emphasized the innovative treatment's immune-mediated mechanism of action, as evidenced by translational data from the AWARE-1 study in breast cancer patients.

Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, expressed gratitude for the productive dialogue with the FDA, marking a vital regulatory milestone. Initiating the registration-enabling trial has become a key objective for the company, alongside the anticipated report of survival data from the BRACELET-1 study in the latter half of the year. Pisano believes these data will enhance the compelling data package and underscore pelareorep's therapeutic potential, aiming to improve the standard of care for breast cancer patients with unmet medical needs.

In other industry developments, GSK plc reported positive results from the DREAMM-8 phase III trial, evaluating belantamab mafodotin in combination with pomalidomide and dexamethasone (PomDex) versus a standard of care in relapsed or refractory multiple myeloma. The combination treatment reduced the risk of disease progression or death by nearly 50%, presenting a significant advancement in multiple myeloma therapy.

Guardant Health, Inc. announced the launch of an enhanced version of its Guardant360 TissueNext test, expanding the number of genes identified in tumor tissue samples to 498. This upgrade aims to provide more comprehensive gene coverage, aiding oncologists in making better-informed treatment decisions for advanced cancer patients.

Exelixis, Inc. settled patent litigations with Cipla Ltd. concerning generic versions of CABOMETYX (cabozantinib) tablets. Earlier this year, Exelixis reported results from its Phase 3 CONTACT-02 trial, where cabozantinib combined with atezolizumab showed a 35% reduction in disease progression or death risk in metastatic castration-resistant prostate cancer.

Gilead Sciences, Inc., through its subsidiary Kite, presented new analyses for Yescarta in relapsed/refractory large B-cell lymphoma at the European Hematology Association Annual Congress. The data highlighted the manufacturing and product characteristics of Yescarta, supporting its potential benefit in earlier treatment lines and the feasibility of outpatient CAR T-cell therapy administration.

These advancements by leading biotech companies underscore the ongoing efforts and innovations within the oncology sector, aiming to meet the rising demand for effective cancer treatments and improve patient outcomes.