PALM BEACH, Fla., Dec. 26, 2024 (GLOBE NEWSWIRE) — FN Media Group News Commentary – The breast cancer drugs market is experiencing rapid expansion due to the diverse applications of drugs in various breast cancer treatment scenarios. Predominantly utilized before and after surgery, these drugs are pivotal in managing the disease. Significant research efforts are focused on targeted therapies tailored to specific breast cancer types, particularly those characterized by overexpression of human epidermal growth factor receptor 2 (HER2). HER2-positive breast cancers, constituting 15% to 20% of cases, exhibit heightened aggressiveness, necessitating targeted interventions. Targeted drug therapy, including immunotherapy, directly addresses proteins on cancer cells, impeding their growth and proliferation. With HER2-targeted drugs demonstrating efficacy in inhibiting tumor progression, the market witnesses a surge in the development and adoption of such therapies to meet the demand for more effective treatments in combating breast cancer. According to a report from BioSpace, the global breast cancer drugs market size, which was valued at USD 32.93 billion in 2023 is projected to surpass around USD 78.61 billion by 2033, registering a CAGR of 9.09% over the forecast period of 2024 to 2033. North America dominated the market with the largest revenue share of 38.61% in 2023. Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), GSK plc (NYSE: GSK), AstraZeneca PLC (NASDAQ: AZN), AbbVie (NYSE: ABBV), Cardiff Oncology, Inc. (NASDAQ: CRDF).
The BioSpace report said: “Breast cancer, the second most common cancer globally, presents a significant market opportunity driven by several key factors. With breast cancer ranking as the most prevalent cancer in the U.S., affecting 1 in 8 women over their lifetime, heightened awareness and advancements in detection and treatment have significantly improved survival rates, with 90% of women surviving five years post-diagnosis. globalization and economic growth may contribute to increased incidence rates, particularly in developing countries where rates are projected to rise by 64% to 95%, and in developed countries with an expected increase of 32% to 56%. Demographic trends reveal distinct patterns, with urban areas seeing higher incidence rates among individuals aged 40–49, while rural areas report elevated rates in those aged 65–69. These demographic shifts, coupled with the imperative for earlier detection and more advanced treatment options, underscore the driving forces behind the continued expansion of the breast cancer drugs market.”
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) Highlights 2024 Achievements and Prepares for an Influential 2025 with Promising Breast and GI Cancer Data – Oncolytics Biotech® Inc., ($ONCY $ONC), a leading clinical-stage company specializing in immunotherapy for oncology, is providing a recap of the major accomplishments from 2024 and a preview of the milestones that are expected over the next 12 months. Following the promising BRACELET-1 readout, Oncolytics expects additional data readouts across our clinical development program in 2025, forming what it believes is a clear pathway to future commercialization opportunities.
“This past year produced highly encouraging clinical developments that we believe set the stage for significant progress, headlined by the robust efficacy results from the BRACELET-1 breast cancer study,” said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. “In addition, our gastrointestinal cancer program continues to impress, resulting in meaningful collaborations with well-respected experts in the field. Key opinion leaders in both breast and GI cancers continue to be excited by pelareorep’s potential as we move into 2025. Based on these insights from leading oncologists, we believe pelareorep has the potential to become a transformational immunotherapy – and that pelareorep-based combination therapies could accelerate our path toward regulatory approval. We are very optimistic about our plans for the next year, and we look forward to showcasing our latest clinical progress early in the new year at the ASCO GI Symposium – an event that could provide key catalysts for our ongoing gastrointestinal cancer programs. Unlike many immunotherapies that struggle to convert ‘cold’ tumors to ‘hot,’ pelareorep’s unique mechanism of action following intravenous delivery has shown the potential to significantly boost patients’ immune responses – making previously unresponsive tumors more susceptible to treatment. I would like to say thank you to our shareholders, clinical collaborators, study sites and their staff, the patients who participate in our trials, and the employees of Oncolytics who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey.”
BRACELET-1’s highly promising results lay a foundation for what we anticipate could be a pivotal, registration-enabling study, further aligning with our long-term goal of improving patient treatment options in metastatic breast cancer
In September, we reported final efficacy results from BRACELET-1, a randomized controlled study that showed marked clinical benefit in patients who received pelareorep-based combination therapy, reinforcing our confidence in pelareorep’s ability to improve patient outcomes. These results included an estimated median overall survival benefit that exceeded one year and a two-year overall survival rate that was nearly double paclitaxel monotherapy (link to press release). Of note, the cohorts were well-balanced across key characteristics, including age, stage of disease, and prior lines of therapy, and pelareorep + paclitaxel demonstrated a favorable overall safety profile. BRACELET-1 also substantiates the results of our earlier IND-213 study, in which median overall survival in HR+/HER2- metastatic breast cancer patients was nearly doubled in patients treated with pelareorep + paclitaxel. Importantly, we also had a productive meeting with the FDA to present our breast cancer data and to align on key elements of our breast cancer program (link to the press release). This includes the use of progression-free survival as the primary endpoint in the planned registration-enabling study, which we believe will allow us to reach the final analysis within two years of the start of enrollment. If results from this registration-enabling study are similar to those observed in BRACELET-1, we believe they will provide a compelling basis for an accelerated approval application that could ultimately lead to making pelareorep available to approximately 55,000 patients in the US in need of better treatment options. We look forward to beginning enrollment into this study as soon as possible and providing more details as they become available.
Collaboration with GCAR on pancreatic cancer study – Our compelling data set in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) has provided us with opportunities to potentially help thousands of patients in this difficult-to-treat disease. We are excited to be working with the Global Coalition for Adaptive Research (GCAR) on a registration-enabling study for pelareorep in metastatic PDAC (link to press release). After more than doubling the objective response rate compared to historical control trials in cohort 1 of the GOBLET study, multiple key opinion leaders suggested we move the combination of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab directly into a study that could support regulatory approval. GCAR has a proven history of designing studies that could accelerate the registrational study timeline and provide substantial cost savings compared to traditional phase 3 trials. We continue to work together to finalize the master protocol and expect to engage with the FDA on our plans in the first half of 2025. Having already collaborated with Roche on GOBLET, we are excited Roche will participate in this registration-enabling study as well.
Progress on the PanCAN-supported pancreatic cancer cohort of GOBLET – Another exciting collaboration stemming from our pancreatic cancer data is with The Pancreatic Cancer Action Network (PanCAN). PanCAN provided the funding for a new GOBLET study cohort evaluating pelareorep + modified FOLFIRINOX (mFOLFIRINOX), with and without atezolizumab, in metastatic pancreatic cancer patients. We dosed the first patient in this cohort in June, completed safety run-in enrollment in Q4 of this year, and received favorable safety feedback from the Data Safety Monitoring Board (DSMB) earlier this month. This cohort represents an important opportunity to evaluate novel treatment options for this very difficult-to-manage disease and may form the basis for an additional pelareorep registrational path. As previously announced, we will be presenting data from this cohort at the ASCO GI Symposium in January 2025 (link to the press release).
Enrollment expansion in anal cancer provides another possible registrational study opportunity – Earlier this year, we expanded enrollment into cohort 4 of the GOBLET study, which is evaluating pelareorep and atezolizumab in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) (link to press release). We previously reported objective response rate data that roughly tripled historical control data and believe 18 patients of additional data could be sufficient to move to a registration-enabling study. While this is an uncommon cancer, the opportunity to improve treatment options would be profoundly impactful for patients and would serve as validation of pelareorep’s potential, including its ability to synergize checkpoint inhibitors like atezolizumab. Additional efficacy data from this cohort will be reported at ASCO GI in January 2025. CONTINUED… Read these full press releases and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/
Other recent oncology developments in the biotech industry of note include:
GSK plc (NYSE: GSK) recently announced statistically significant and clinically meaningful overall survival (OS) results from a planned interim analysis of the DREAMM-7 trial evaluating belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) versus daratumumab in combination with bortezomib plus dexamethasone (DVd) as a second line or later treatment for relapsed or refractory multiple myeloma. These data were featured today in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.
The OS findings from DREAMM-7 build on previous data from the DREAMM-71and DREAMM-82 trials, which showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for both belantamab mafodotin-based combinations versus standard of care comparators.
AstraZeneca PLC (NASDAQ: AZN) – Updated results from the OlympiA Phase III trial showed AstraZeneca and Merck & Co., Inc’s, known as MSD outside of the US and Canada, LYNPARZA® (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) at six years for patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.
LYNPARZA also demonstrated sustained and clinically meaningful improvements in the primary and secondary endpoints of IDFS and DDFS. LYNPARZA reduced the risk of invasive breast cancer recurrence, second cancers or death by 35% (HR 0.65; 95% CI; 0.53-0.78) and reduced the risk of distant disease recurrence or death by 35% (HR 0.65; 95% CI; 0.53-0.81) versus placebo. The benefit with LYNPARZA was consistent across all key subgroups, including patients with high-risk, hormone-receptor-positive disease.
AbbVie (NYSE: ABBV) recently announced new results from two ongoing clinical trials evaluating epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma (DLBCL) at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH).
Arm 1 of the Phase 1b/2 EPCORE® NHL-2 multi-arm trial evaluates fixed-duration investigational epcoritamab in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in untreated high-risk DLBCL patients (n=46) with International Prognostic Index (IPI) scores of 3 to 5 (Abstract #581). Results from this arm of the study showed an overall response rate (ORR) of 100% and a complete response (CR) rate of 87%. Among complete responders, an estimated 83% remained in remission after two years. Separately, three-year follow-up results from the Phase 2 EPCORE® NHL-1 trial (Abstract #4480), evaluating epcoritamab monotherapy in challenging-to-treat adult patients (n=157) with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy showed that among the 41% of patients who achieved a CR, an estimated 52% were still responding at three years (median CR duration: 36.1 months).
Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy and safety data are for all evaluable patients as of a November 26, 2024 data cut-off date, and all efficacy data are determined by a blinded, independent central review (BICR) of each patient’s tumor scan.
“We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses.”
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