Palm Beach, FL – September 20, 2024 – Breast cancer is an illness in which the breast cells get uncontrollably large. The type of breast cancer depends on which cells in the breast become cancerous. Cancer cells removed during the biopsy are examined to check the presence of progesterone or estrogen receptor proteins. The hormones, i.e. estrogen and progesterone, encourage cancer growth when they bind to these receptors. If these receptors are present, cancers are classified as hormone receptor-positive or hormone receptor-negative (proteins). Breast cancer develops due to reasons, such as BRCA gene mutation and PIK3CA gene mutation etc. Ducts and lobules are the major components of a breast, and everything is held together by the connective tissue which surrounds it. Breast cancer develops where the ducts or lobules are located, and it can spread to other body parts via blood and lymph arteries. Breast cancer is metastasized when it spreads to other body regions. Advanced breast cancer is another word for metastatic breast cancer. Advanced breast cancer is defined in medical terms as breast cancer that has gone beyond the breast to other essential organs in the body, such as the bones, lungs, liver, or brain, to mention a few. Metastatic breast cancer usually develops months or years after a person has finished treatment for an early or locally advanced variety of breast cancer, such as stage I, II, or III. As a result, metastatic breast cancer is also known as distant recurrence. A report from Strategic Market Research predicted that the global metastatic breast cancer treatment market is expected to expand at a CAGR of 10.4% to reach $41.74 billion by 2030 during the period 2021-2030. The report said: “The most commonly prescribed treatments for metastatic breast cancer are chemotherapy and radiation therapy. Both of these treatments help to slow tumor growth. On the other hand, hormone therapy is the most successful treatment since it helps to limit the growth of cancer cells. The metastatic breast cancer treatment market trends like the introduction of more advanced technologies and rising demand for metastatic breast cancer therapies are some of the primary drivers driving the global market’s growth.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), Merck (NYSE: MRK), Pfizer Inc. (NYSE: PFE), Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD).
Strategic Market Research concluded: “The increased investments in research & development and increasing cancer diagnostics awareness campaigns are expected to assist this market to grow significantly in the upcoming years… The market is also expected to rise as reimbursement policies has improved significantly. Because of the vast patient pool, government initiatives, and government financing to discover innovative medicines and improve healthcare conditions.”
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study – Oncolytics Biotech ® Inc., ($ONCY $ONC), a leading clinical-stage company specializing in immunotherapy for oncology, announced positive clinical results from BRACELET-1, its randomized Phase 2 study evaluating pelareorep in patients with HR+/HER2- advanced or metastatic breast cancer.
Final BRACELET-1 Results – Final BRACELET-1 efficacy data were collected and analyzed two years after the last patient was enrolled as specified by the protocol. Results of the final BRACELET-1 analysis show that the median OS was not reached in the pelareorep + paclitaxel arm, as more than half of the patients in that arm remained alive at study end. In contrast, median OS for the paclitaxel monotherapy arm was 18.2 months, and the hazard ratio was 0.48 for pelareorep + paclitaxel vs. the paclitaxel monotherapy. Had study follow-up continued beyond two years, and patients survived only until the next planned visit (in four months), the median OS for patients in the pelareorep + paclitaxel arm would be 32.1 months. In accordance with these results, the two-year survival rate for patients in the pelareorep + paclitaxel arm was 64% compared to 33% for paclitaxel monotherapy patients. Additionally, the final median progression-free survival (PFS) for BRACELET-1 was 12.1 months in the pelareorep + paclitaxel arm vs. 6.4 months in the paclitaxel monotherapy arm, representing a 5.7-month benefit with a hazard ratio of 0.39.
Confirmed overall response rate (ORR) was 37.5% for pelareorep + paclitaxel and 13.3% for paclitaxel. As previously reported, ORRs at week 16 (the trial’s primary endpoint) in the pelareorep + paclitaxel and paclitaxel monotherapy cohorts were 31% and 20%, respectively.
“The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us,” said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. “It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy.”
Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, commented, “The overall survival and final progression-free survival results from the BRACELET-1 final analysis exceeded our expectations. In addition, our translational data strongly suggest that the OS benefit was linked to pelareorep’s immunologic activity. Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer. Moreover, these results substantiate the statistically significant near doubling of median overall survival observed in the earlier randomized IND-213 study in a similar patient population treated with pelareorep + chemotherapy compared to chemotherapy alone. Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer.”
Professor Martine J. Piccart , M.D., Ph.D. Université Libre de Bruxelles commented, “While there has been progress in the treatment of advanced and metastatic breast cancer, an unmet medical need remains. With the encouraging results of BRACELET-1 and the prior positive results of the IND-213 study, pelareorep should continue to be developed and evaluated in the clinical setting.” CONTINUED… Read these full press releases and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/
Other recent cancer developments in the biotech industry of note include:
Novartis AG (NYSE: NVS) recently announced that the US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease.
The approval is based on results from the pivotal Phase III NATALEE trial, which showed a significant and clinically meaningful 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006) reduction in risk of disease recurrence in a broad population of patients with HR+/HER2- stage II and III EBC treated with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone, including those with high-risk N0 disease. The invasive disease-free survival (iDFS) benefit was consistently observed across all patient subgroups.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, recently announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
The approval is based on data from the pivotal Phase 2/3 IND.227/KEYNOTE-483 trial. In IND.227/KEYNOTE-483, KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; p=0.0162) compared to chemotherapy alone at the trial’s pre-specified final analysis. Median OS was 17.3 months (95% CI, 14.4-21.3) for KEYTRUDA plus chemotherapy versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. KEYTRUDA plus chemotherapy also significantly improved progression-free survival (PFS) versus chemotherapy alone (HR=0.80 [95% CI, 0.65-0.99], p=0.0194; median PFS 7.1 months [95% CI, 6.9-8.1] versus 7.1 months [95% CI, 6.8-7.7], respectively). Overall response rate (ORR) was significantly higher for KEYTRUDA plus chemotherapy versus chemotherapy alone (52% [95% CI, 45.5-59.0] versus 29% [95% CI, 23.0-35.4], respectively; p<0.00001). Adverse reactions occurring in patients with MPM were generally similar to those in other patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy.
Pfizer Inc. (NYSE: PFE) recently announced its Phase 2 study of ponsegromab, a monoclonal antibody directed against growth differentiation factor-15 (GDF-15), met its primary endpoint of change from baseline in body weight compared to placebo in people with cancer cachexia and elevated levels of GDF-15. Cachexia is a common, life-threatening wasting condition that can significantly impact quality of life in affected patients with cancer.ii,iii Results will be presented today as a late-breaking Proffered Paper Presentation (LBA82) at the European Society for Medical Oncology (ESMO) 2024 Congress and have simultaneously been published in The New England Journal of Medicine (NEJM).
“Cachexia is a common condition in cancer patients, associated with weight loss, functional decline, and ultimately poor outcomes. Despite the number of people suffering from cachexia, there are no available options for us to help treat patients,” said Jeffrey Crawford, M.D., George Barth Geller Professor for Research at Duke Cancer Institute, and principal investigator. “This study showed us those who received ponsegromab had improvement in body weight, muscle mass, quality of life, and physical function. These findings offer hope that a breakthrough targeted treatment is potentially on the horizon for our patients.”
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced recently that based on the recently published results from the Open-Label part of its Phase 3 NASH study, new scientific publications on the role of SCD1 as a critical metabolic signaling hub as well as an extended cash runway, it plans to broaden its drug development activities.
The planned expansion consists of two additional programs over the next two years. One program aims to identify novel Aramchol-based drug combinations to overcome resistance to standard-of-care oncological treatments for patients with advanced colorectal and hepatic cancers. Another program aims to unravel new mechanisms of action that will allow the development of a novel Aramchol-based drug combination targeting cardiac fibrosis, or scarring of the heart, which occurs in many cardiovascular diseases that can lead to heart dysfunction and failure. The Company plans on releasing new data from in-vitro and ex-vivo studies in these programs during the fourth quarter of 2024.
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