A significant medical breakthrough is sorely needed in the fight against breast cancer. According to the American Cancer Society, more than 3.1 million women in the United States have a history of invasive breast cancer. And breast cancer deaths are estimated to be more than 43,000 per year – making it the second leading cause of cancer death in women. However, there may be hope on the horizon, with companies such as BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT), Pfizer (NYSE: PFE), Gilead Sciences (NASDAQ: GILD), Puma Biotechnology (NASDAQ: PBYI), and Merck (NYSE: MRK) leading the charge against cancers. We should also point out that, according to Research and Markets.com, the global breast cancer drug market could be worth $27.04 billion by 2026. In addition, Global Markets Insights says that number could be closer to $43 billion by 2028, with further advances in breast cancer care.
Look at BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT), For Example
BriaCell Therapeutics, a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is presenting positive clinical data from its lead product candidate, Bria-IMT™, summarized in four poster sessions during the 2023 American Association for Cancer Research (AACR) Annual Meeting held from April 14 – 19, 2023 at Orange County Convention Center, Orlando, Florida.
“Our data highlights the potential clinical value of the Bria-MT™ regimen in patients with advanced metastatic breast cancer after receiving multiple prior therapies.” Said Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate Professor of Clinical Medicine, Principal Clinical Investigator, and co-author of the study of Bria-IMT™ in combination with PD-1 inhibitors pembrolizumab and retifanlimab. “These results are promising and the fact that patients have had a great quality of life thus far is remarkable. We are hopeful that this novel immunotherapy proves to be an effective therapy for our patients.”
“Our clinical findings continue to confirm our approach for our upcoming pivotal trial of Bria-IMT™ combination regimen,” commented Dr. William V. Williams, BriaCell’s President and CEO. “With over 40,000 annual deaths in the U.S. alone, advanced metastatic breast cancer remains an unmet medical need. Patients who have only months to live tend to avoid current therapies that are proven ineffective and are associated with excessive toxicities. BriaCell’s regimen has shown robust clinical efficacy, better than expected survival outcomes, and an excellent safety profile in this very difficult to treat patient cohort. We are seeing benefits in patients who failed other treatments and/or cannot tolerate the harsh side effects of other therapies.”
The posters are summarized below and linked here: https://briacell.com/scientific-publications/. In fact, here are some highlights from the company’s first of four accepted posters.
Poster 1 – Title: Whole cell antigen presenting immune stimulating cells (Bria-IMT™) for the treatment of metastatic breast cancer
Strong Progression Free Survival and Clinical Benefit
Progression Free Survival (PFS) is the length of time during which a patient’s cancer does not get worse and is used as a key survival and efficacy measurement. PFS benefit was observed in BriaCell’s combination regimen (with PD1 inhibitor pembrolizumab (n=11) or retifanlimab (n=20)), as measured by PFS difference from a patient’s previous therapy (prior to enrolment in BriaCell’s study). Most patients’ PFS values were similar or higher than those of their prior regimen, a positive finding that suggests better tolerability, clinical effectiveness, and survival time. Patients treated with Bria-IMT™ remained on treatment for a longer period of time than expected. BriaCell’s patient cohort would have typically experienced shorter time on therapy with each subsequent line of treatment, given their advanced cancer stage.
Survival Update:
The data suggest a survival benefit in this group of difficult to treat patients who had failed multiple prior treatments and who had a typical life expectancy of 6 months or less.
Other related developments from around the markets include:
Pfizer announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. In the U.S., BRAFTOVI + MEKTOVI is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Kite, a Gilead Sciences’ company, announced the primary overall survival (OS) analysis results of the Phase 3 ZUMA-7 study. The results showed a statistically significant improvement for Yescarta in OS versus historical treatment, which was the standard of care (SOC) in a curative setting for nearly 30 years, for initial treatment of adult patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy. Historical SOC is a multi-step process involving platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy (HDT) and stem cell transplant (ASCT) in those who respond to salvage chemotherapy. These findings will be presented in full later this year at an upcoming scientific meeting.
Puma Biotechnology, a biopharmaceutical company, announced that the results of the Phase II TBCRC041 randomized clinical trial of alisertib alone or in combination with fulvestrant in patients with endocrine-resistant advanced breast cancer have been published online in JAMA Oncology. Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. The Phase II randomized clinical trial was conducted through the Translational Breast Cancer Research Consortium. The trial enrolled postmenopausal women with endocrine-resistant, HER2–negative metastatic breast cancer who were previously treated with fulvestrant. For the 91 evaluable patients, baseline characteristics were well-balanced between the two arms of the trial; however, more patients in the alisertib plus fulvestrant arm had been previously treated with chemotherapy in the metastatic setting (47.8% in the alisertib alone arm, 68.9% in the alisertib plus fulvestrant arm). 100% of the patients in each arm of the trial were previously treated with CDK 4/6 inhibitors. 37% of the patients in the alisertib alone arm and 57.8% of patients in the alisertib plus fulvestrant arm were previously treated with everolimus.
Merck, known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The sBLA is based on data from the KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) versus chemotherapy alone, regardless of PD-L1 expression, in patients who were human epidermal growth factor receptor 2 (HER2) negative. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 16, 2023.
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