FinancialNewsMedia.com News Commentary
PALM BEACH, Fla., May 26, 2023 /PRNewswire/ — Metastatic breast cancer is the advanced stage of breast cancer, including cases wherein cancer has spread to the other parts of the body from the breast. It is also known as stage IV breast cancer. Some of the most common organs which are affected by metastatic breast cancer include the lungs, bones, brain, and liver. Although this cancer has spread to other parts of the body, it is diagnosed as breast cancer only. Usually, metastatic breast cancer may be detected months or years after the advanced or early detection and treatment of breast cancer such as stages 1, 2, or 3. Globally increasing awareness and development of new therapies and drugs is expected to drive the demand for the metastatic cancer industry through 2031. A report from Absolute Reports projects that the global Metastatic Breast Cancer Treatment market size was valued at USD 16140.95 million in 2022 and is expected to expand at a CAGR of 11.71 Percent during the forecast period, reaching USD 31366.56 million by 2028. Another report from Transparency Market Research added: “Chemotherapy and radiation therapy are the most diagnosed therapies used to cure metastatic breast cancer. Both these therapies help in suppressing tumor growth. Besides this, hormone therapy is considered the most effective therapy as it helps to restrict the expansion of the cancer cell. Such therapies are projected to augment the market share, thereby boosting the growth of the metastatic breast cancer market during the forecast period (2031). Factors augmenting the growth of the metastatic breast cancer market include the rise in cases of HER2-positive breast cancer worldwide. This will ultimately increase the demand for novel drugs to treat metastatic breast cancer, which is already in the fourth stage. Moreover, favorable reimbursement policies in developed economies and the rising adoption of immunotherapy are further expected to bolster the growth of the metastatic breast cancer market at a global level… through 2031.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Pfizer Inc. (NYSE: PFE), Ocean Biomedical (NASDAQ: OCEA), Novartis AG (NYSE: NVS), Relay Therapeutics, Inc. (NASDAQ: RLAY).
It added: “The rising investments in research and development by various manufacturing companies and increasing awareness programs on cancer diagnostics are likely to help this market witness significant growth opportunities in the years to come. It concluded: “Regionally, North America held the dominant share in the global metastatic breast cancer market owing to the presence of well-established healthcare infrastructure, availability of advanced facilities, and best medical practitioners. This coupled with the growing awareness about breast cancer and the willingness of people to spend on medicine will further help this region continue dominating the market in the coming years.”
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech® Announces Positive Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial Demonstrating Pelareorep Drives ≥50% Improvements in ORR and mPFS in an ASCO Annual Meeting Abstract –
- 31% week-16 overall response rate and 9.6-month median progression-free survival with pelareorep plus paclitaxel vs. 20% and 6.4 months with paclitaxel alone as of Oct. 2022 ASCO abstract cut-off date
- Updated data from May 2023 cut-off date will be presented in an oral presentation on June 3, 2023
- Oncolytics to advance to registrational study of pelareorep-paclitaxel combination in HR+/HER2- breast cancer
Oncolytics Biotech® today announced positive results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. The results are published in an abstract accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2 – 6, 2023 in Chicago, Illinois and online. The abstract is available on the ASCO Annual Meeting website.
BRACELET-1 enrolled 48 patients randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio®). All participants enrolled in the trial previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor.
Compared to the paclitaxel monotherapy cohort, the cohort evaluating the combination of paclitaxel plus pelareorep showed ≥50% improvements on the trial’s primary endpoint of overall response rate (ORR) at week 16 (31.3% vs. 20%) as of the ASCO abstract cut-off date (October 2022). This cohort also reported median progression-free survival (mPFS) of 9.6 months vs. 6.4 months as of the cut-off date. Overall survival data from the trial continue to mature. Data from this study validate the results of IND-213, a prior phase 2 trial that showed a statistically significant near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep combined with paclitaxel (21.0 months, n = 28) vs. those treated with paclitaxel alone (10.8 months, n = 29).
“BRACELET-1 substantially de-risks our HR+/HER2- breast cancer program by providing a second randomized dataset showing pelareorep plus paclitaxel outperforming paclitaxel alone,” said Dr. Matt Coffey, President and Chief Executive Officer. “Importantly, evidence of pelareorep’s ability to synergistically enhance paclitaxel’s efficacy has now been seen consistently across multiple clinical efficacy endpoints of overall survival, progression-free survival, and ORR. With these data, our program is phase 3-ready, and efforts to expeditiously advance to a two-arm registrational study of pelareorep-paclitaxel combination therapy are well underway. I would like to thank BRACELET-1’s participants as well as our collaborators at Pfizer, Merck KGaA, Darmstadt, Germany, and PrECOG, all of whom contributed to an important trial that will inform and accelerate pelareorep’s path to approval.” CONTINUED… Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/
Other recent breast cancer developments in the biotech industry of note include:
Pfizer Inc. (NYSE: PFE) and Thermo Fisher Scientific Inc. (TMO) recently announced they have entered into a collaboration agreement to help increase local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia where advanced genomic testing has previously been limited or unavailable. Access to local NGS testing can help to provide faster analysis of associated genes, empowering healthcare providers to select the right therapy for that individual patient.
Cancer is a leading cause of death globally, accounting for nearly 10 million deaths in 2020, or around one in six deaths. Breast and lung cancer are the leading types of cancer diagnosed and are responsible for almost 4.5 million deaths worldwide. By 2040, the global burden for cancer is expected to grow to 27.5 million new cancer cases and 16.3 million cancer deaths. Under the agreement, Thermo Fisher will identify local labs that will be using the company’s NGS technology and ensure they have the necessary infrastructure, trained staff, and quality control measures to meet industry standards for NGS testing services for breast and lung cancer. Pfizer will explore ways to enable affordable patient access for NGS testing for these types of cancer and work to raise healthcare provider awareness regarding the benefits of advanced testing. The two companies will continue to evaluate opportunities to expand geographically and to expand testing for other types of cancer.
Ocean Biomedical (NASDAQ: OCEA) announced recently that its Scientific Co-founder, Dr. Jack A. Elias, MD, has been issued a broad patent for his cancer immunotherapy discovery related to reversing immune system suppression by binding chitinase 3-like-1 (CHi3L1) polypeptides with Ocean Biomedical’s proprietary immunoglobulin antibody. This process has been shown to suppress primary and metastatic tumor growth in multiple animal models and has potential use in multiple forms of visceral cancers.
Ocean Biomedical’s monoclonal antibody is one component of a unique oncology platform that is building multiple approaches to activating natural anticancer immune responses by suppressing CHi3L1, with potential for broad application. The patent has been granted for prostate cancer, colon cancer, rectal cancer, ovarian cancer, kidney cancer, breast cancer, glioblastoma, melanoma, and lung cancer. The newest claims dovetail issued patents with claims coverage focused on composition of matter of monoclonal antibodies targeting and inhibiting CHi3L1.
Novartis AG (NYSE: NVS) recently announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali® (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at risk of recurrence. The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met. Kisqali plus ET significantly reduced the risk of disease recurrence, compared to standard adjuvant ET alone, with consistent benefit in patients with stage II and stage III EBC regardless of nodal involvement.
“While most patients are diagnosed and treated early with the aim to cure breast cancer, the risk of cancer returning, often as metastatic disease, peaks within three years after diagnosis, but never goes away completely,” said Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center and Chairman and Executive Director of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator. “There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life. The NATALEE trial, where ribociclib was given for three years plus ET, was designed with these unmet needs in mind, and it is extremely encouraging that this study met its primary endpoint.”
Relay Therapeutics, Inc. (NASDAQ: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, recently announced initial clinical data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα. The data support initial clinical proof of mechanism, demonstrating that RLY-2608 achieved selective target engagement at multiple predicted efficacious doses with a favorable initial safety and tolerability profile. These data are being presented today at the American Association for Cancer Research (AACR) Annual Meeting 2023.
“While early, these data suggest that by selectively inhibiting mutant PI3Kα and avoiding key off-target toxicities that typically limit the use of non-selective PI3Kα pathway inhibitors, RLY-2608 has the potential to transform treatment for patients with a broad range of PI3Kα mutations,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. “At doses achieving target exposure, there was no observed Grade 3 hyperglycemia, rash or diarrhea – the three most common adverse events leading to discontinuation of existing investigational and approved treatments, and radiographic tumor reductions were seen across multiple dose levels. We are continuing dose escalation and expect to initiate expansion cohorts in the second half of 2023.”
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