USA News Group – The American Cancer Society is projecting 2024 to be the first year ever for the US to have more than 2 million new cases, which would represent a record high. Among 10 of the most common cancers, 6 have seen a rise in diagnoses, including the most common type of cancer in women—breast cancer. According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022, and is predicting a 77% increase in new cancer cases by 2050. Based on the characteristics of each patient’s tumor, how each patient is treated may be completely different from others. Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).
Coming off of a late-2022 FDAFast Track Designation of Oncolytics Biotech Inc.’s (NASDAQ:ONCY) (TSX:ONC) flagship asset pelareorep for the treatment of pancreatic cancer, momentum is building towards another important FDA milestone, this time for breast cancer. Oncolytics recently announced the submission of a Type C meeting request to the FDA to discuss its new planned trial for pelareorep in treating HR+/HER2- metastatic breast cancer (mBC).
“A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment,” said Matt Coffey, President and CEO of Oncolytics. “We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and registration.”
According to Dr. Coffey, Oncolytics’ ongoing discussions with its clinical collaborators and partners have helped the company to prepare a robust, compelling briefing document. Oncolytics eagerly anticipates this discussion in Q2 2024 with the FDA to align on the design and objectives of the trial design for pelareorep in metastatic breast cancer, a critical step towards bringing this innovative treatment to patients. With anticipated overall survival data from its BRACELET-1 study and productive discussions with the FDA, Oncolytics expects 2024 to be a transformative year for the company and its stakeholders.
“The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients.”
Last year was a big year for Gilead Sciences, Inc. (NASDAQ:GILD) and its Trodelvy that gained FDA approval in pre-treated HR+/HER2- metastatic breast cancer in February 2023. This helped to increase Gilead’s Trodelvy revenue to reach blockbuster status in 2023, growing 56[JP1] % from the year prior. Despite missing on its main goal for its lung cancer trial, Gilead is pushing forward with Trodelvy and the company’s role in the fight against breast cancer through the launch of a patient hub to expose the realities of living with metastatic breast cancer, dubbed Expose MBC.
“We created Expose MBC because we’ve learned from the metastatic breast cancer community that they still feel unheard and unseen,” said a Gilead spokesperson in a statement sent to Fierce Pharma. “Early breast cancer stories and positive stories of survivorship can feel overshadowing. And the metastatic TNBC community has few dedicated resources.”
After a setback from the reaction to an update to its PRESERVE 2 phase 3 breast cancer study in February 2024, G1 Therapeutics, Inc. (NASDAQ:GTHX) pressed onward with the trial for its Trilaciclib in metastatic triple-negative breast cancer following interim analysis by the independent Data Monitoring Committee (DMC). Trilaciclib is given through an IV that blocks certain proteins (CDK4/6) to help protect the bone marrow and immune system when a patient is getting chemotherapy.
“We remain confident in the ability of trilaciclib to ultimately achieve the OS primary endpoint based on the robust survival benefit demonstrated in the prior randomized Phase 2 study, which continued to meaningfully increase over time as patients received subsequent therapies, as well as the increased statistical power for the final analysis of this pivotal study,” said Jack Bailey, CEO of G1 Therapeutics. “While a positive interim analysis would have enabled us to bring this therapy to patients in need sooner, we look forward to completing the study and potentially making this meaningful new treatment option available to patients with this highly aggressive form of breast cancer as early as next year.”
The DMC looked at the early data and said it's safe to keep going with the study without any changes. They're planning to do a final check in Q3 2024 to see how long patients live (Overall Survival) who are part of the study.
For breast cancer patients whose tumors were HER2-negative but harbored certain deficiencies, AstraZeneca PLC’s (NASDAQ:AZN) selective PARP1 inhibitor showed encouraging safety and efficacy at this year’s AACR24 conference. The results have, in some ways, surprised researchers, including the University of Texas MD Anderson Cancer Center’s Dr. Timothy Yap, who can’t pinpoint why AstraZeneca’s saruparib seems to be spurring responses in patients who haven’t had much luck with others in the PARP inhibitor drug class.
“It is something that I've been scratching my head on ever since we presented the case, two years ago at this meeting,” said Dr. Yap at an AACR press conference. “One could argue that we have a better drug here, that we're achieving much higher drug exposures in patients.”
The first study on saruparib, shared by Dr. Yap from the Phase 1/2a PETRA trial, found that out of 31 patients who got the right dose, about 49% saw their cancer shrink or stop growing. On average, these patients didn't see their cancer get worse for about 9.1 months.
Another major portion of the fight against breast cancer comes from improved screening. Hot off of winning the first-ever Coolest Thing Made in Delaware Contest, Hologic, Inc. (NASDAQ:HOLX) and its 3D Mammography System hold 80% of the market share in the USA for all mammography systems.
“Our administrator for our site, yesterday she rang the bell for her breast cancer after she finished her last treatment,” said Brian Brooks, Senior Director of Operations for Hologic. “She had early detection screened on one of our 3D mammography systems.”
Unfortunately, Hologic also received a setback in February 2024 with its BioZorb Marker and BioZorb LP Marker devices, which are implanted into soft tissue, including breast tissue, where the site needs to be marked for future procedures, including radiation for breast cancer treatment. After a further review of reports, the FDA has warned patients and healthcare providers about the potential risk of serious complications arising from the use of these devices.
But these devices aren’t Hologic’s only offerings in the breast cancer arena. Through its subsidiary Biotheranostics, Inc., the company also offers its Breast Cancer Index® (BCI) test, which demonstrably led to physicians changing their long-term anti-estrogen treatment recommendations for 40% of patients with early-stage hormone receptor-positive (HR+) breast cancer.
“For many physicians, the test results changed their recommendations for prescribing or not prescribing extended anti-estrogen therapy for patients based on the predictive benefit," said Tara Sanft, M.D., the study’s primary author, Associate Professor of Medicine at Yale School of Medicine and Chief Patient Experience Officer at Smilow Cancer Hospital. “The Breast Cancer Index helps us prevent over- and undertreatment for extended anti-estrogen therapy and is an incredibly helpful tool, giving us more confidence in our treatment decisions for breast cancer patients.”
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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