Genentech, Inc.

Calquence is forecast to generate up to $4.7bn in sales by 2030, as per GlobalData intelligence. Credit: Nadezhda Fedrunova via Getty Images. AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib), for first-line use in mantle cell lymphoma (MCL). This approval makes Calquence the first BTK inhibitor available for adults with untreated MCL who are unsuitable for autologous haematopoietic stem cell transplantation (HSCT) and allows its use in combination with chemoimmunotherapy. The FDA granted approval based on data from the Phase III ECHO trial (NCT02972840). The randomised, double-blind, placebo-controlled study enrolled 598 patients aged 65 or older with untreated MCL who were unsuitable for HSCT. Patients were randomised to receive Calquence with chemotherapy bendamustine and Biogen and Genentech’s Rituxan (rituximab) or placebo plus bendamustine and Rituxan. Efficacy was measured by progression-free survival (PFS) and evaluated by an independent review committee. The median PFS was 66.4 months in the Calquence plus BR arm, compared to 49.6 months in the placebo plus bendamustine and Rituxan arm. The trial demonstrated a 27% improvement in PFS for Calquence over placebo. MCL is a rare and aggressive subtype of non-Hodgkin lymphoma, often diagnosed in later stages and characterised by the malignant transformation of B lymphocytes in the lymph node mantle zone. Calquence, a next-generation selective and irreversible BTK inhibitor, binds covalently to the BTK active site to inhibit enzymatic activity, suppressing the proliferation and survival of malignant B cells. AstraZeneca’s Calquence now holds a first-mover advantage in the treatment-naive MCL market, outpacing competitors such as BeiGene’s Brukinsa (zanubrutinib), Eli Lilly’s Jaypirca (pirtobrutinib), InnoCare’s Inokai (orelabrutinib), all of which remain in late-stage clinical trials for this indication. AbbVie and Johnson & Johnson’s (J&J’s) Imbruvica (ibrutinib) was previously positioned to lead the market but lost its accelerated approval in 2023 after the Phase III SHINE trial (NCT01776840) showed no overall survival benefit and a 7% increase in mortality risk for Imbruvica-treated patients. GlobalData projects that Calquence could generate up to $4.7bn in sales by 2030. With this FDA approval, AstraZeneca is poised to capitalise on its lead in the competitive BTK inhibitor market. GlobalData is the parent company of Pharmaceutical Technology.

THURSDAY, Jan. 16, 2025 -- For patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, adjuvant trastuzumab emtansine (T-DM1) improves overall survival more than trastuzumab alone, according to a study published in the Jan. 16 issue of the New England Journal of Medicine . Charles E. Geyer Jr., M.D., from the National Surgical Adjuvant Breast and Bowel Project Foundation in Pittsburgh, and colleagues randomly assigned patients with HER2-positive early breast cancer with residual invasive disease in the breast or axilla after neoadjuvant systemic treatment with taxane-based chemotherapy and trastuzumab to receive 14 cycles of T-DM1 or trastuzumab (743 individuals in each treatment group). With a median follow-up of 8.4 years, the researchers found that T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab (unstratified hazard ratio for invasive disease or death, 0.54; 95 percent confidence interval, 0.44 to 0.66). Seven-year invasive disease-free survival was 80.8 and 67.1 percent with T-DM1 and trastuzumab, respectively. A significantly lower risk for death was seen with T-DM1 versus trastuzumab (unstratified hazard ratio, 0.66; 95 percent confidence interval, 0.51 to 0.87; P = 0.003). Seven-year overall survival was 89.1 and 84.4 percent, respectively, with T-DM1 and trastuzumab. In 26.1 and 15.7 percent of patients in the T-DM1 and trastuzumab groups, respectively, adverse events of grade 3 or higher were noted. "This prespecified long-term follow-up analysis provides additional support for the neoadjuvant therapy paradigm by showing that adjuvant T-DM1 also provided a significant improvement in overall survival and no evidence of long-term safety issues," the authors write. The study was funded by F. Hoffmann-La Roche/Genentech, the manufacturer of trastuzumab emtansine.

New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1 SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients. Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year. "Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed." About GOBLET Cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic PDAC patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab in 2nd line or later advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; continued enrollment in the GOBLET study and the expansion thereof to additional participants; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] Logo - SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED