Atezolizumab

A decade after Bristol Myers Squibb first won approval for its PD-1 checkpoint inhibitor Opdivo, the cancer drug has been approved in a subcutaneous form that’s becoming a new area of competition for the blockbuster class. Following Friday’s FDA approval , the under-the-skin injection will be sold as Opdivo Qvantig. Since Opdivo was originally cleared as an IV infusion in 2014, it has racked up approvals in more than 20 indications across 11 tumor types, Wendy Short Bartie, SVP of BMS’ US oncology & hematology commercialization, said in an interview with Endpoints News . Subcutaneous formats are becoming the next battleground for the treatments, promising greater ease of use than infused drugs that must be given in a clinic. They could also extend the product life for the companies, giving them new patent protection. “We believe that bringing subQ to the market ultimately allows patients to benefit from standard-of-care cancer medicine well into the next decade,” said Short Bartie. Merck’s PD-1 inhibitor, Keytruda, was also first approved in 2014. The two drugs helped open the immunotherapy field and changed how cancer is treated. Keytruda, though, has blown past all others and pulled in $25 billion in 2023. Opdivo brought in $9 billion last year. The subcutaneous form can be delivered in about three to five minutes versus 30 minutes for the IV form, Short Bartie said. “Nobody wants to be constantly reminded that they have cancer, so what we’ve heard from patients is the ability to get in and get out of their doctor’s offices as quickly as possible allows people to get back to work, it allows them to spend more time with their families,” Short Bartie said. Bristol Myers won’t be alone with its new version. Roche’s PD-L1 Tecentriq won a subcutaneous approval earlier this fall. And Merck reported positive Phase 3 data for its subcutaneous Keytruda last month and said it would discuss the results with global regulators “ as soon as possible .” “Overall, I believe, the approval of subcutaneous checkpoint inhibitors fundamentally improves care for patients, irrespective of which therapy the patient is on,” Short Bartie said. The FDA approval of Opdivo’s new format is for previously approved adult solid tumor indications as a monotherapy; as a monotherapy after completion of Opdivo and Yervoy combination treatment; or in combination with chemotherapy or cabozantinib. Short Bartie said BMS expects the subcutaneous approval will apply to about 75% of Opdivo’s business, but won’t apply to Opdivo-Yervoy combinations. And about 30% to 40% of eligible patients are anticipated to transfer from the IV formulation to the subcutaneous one, she said.

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 26, 2024 /PRNewswire/ -- USA News Group News Commentary – Immunotherapy is transforming oncology by harnessing the immune system's power to fight cancer like never before. Notable advancements include a bioengineered therapeutic platform that boosts immune responses, providing targeted solutions for challenging cancer types. Researchers have also introduced an mRNA-based immunotherapy platform capable of selectively targeting cancer cells while preserving healthy tissue. These innovations underscore the relentless pursuit of breakthroughs in oncology to enhance patient outcomes. Among the key players driving recent progress in the field are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Erasca, Inc. (NASDAQ: ERAS), Allogene Therapeutics, Inc. (NASDAQ: ALLO), Context Therapeutics Inc. (NASDAQ: CNTX), and Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX). The article continued: The oncology field continues to advance, with MarketsAndMarkets forecasting the Artificial Intelligence in Oncology Market to reach $11.52 billion by 2030, driven by a 29.4% CAGR. Similarly, Nova Advisor predicts the Personalized Cell Therapy Market will grow at a 23.53% CAGR, reaching $251.37 billion by 2034. Oncolytics Biotech® Highlights 2024 Achievements and Prepares for an Influential 2025 with Promising Breast and GI Cancer Data Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently released a recap of major accomplishments from 2024 and a preview of anticipated milestones for the next 12 months. Following the promising BRACELET-1 readout, Oncolytics expects additional data readouts across its 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 Biotech's 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 Biotech who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey." Oncolytics Biotech continues to advance pelareorep, its innovative immunotherapy for multiple cancer indications. Final efficacy results from the BRACELET-1 study in HR+/HER2- metastatic breast cancer demonstrated a median overall survival benefit exceeding one year and a two-year survival rate nearly double that of paclitaxel monotherapy. These findings, supported by earlier IND-213 data, further reinforce pelareorep's transformative potential. With FDA alignment on a planned registration-enabling study, Oncolytics Biotech aims to offer improved treatment options for approximately 55,000 U.S. patients annually. Significant progress has also been made in pancreatic cancer, with plans for a registration-enabling study supported by collaborations with the Global Coalition for Adaptive Research (GCAR) and Roche. This follows the GOBLET study's outcomes, which more than doubled response rates in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients. Additionally, the PanCAN-funded GOBLET cohort evaluating pelareorep plus mFOLFIRINOX, with or without atezolizumab, has completed safety run-in enrollment, receiving positive feedback from the Data Safety Monitoring Board. Key findings from this cohort, alongside progress in anal cancer, will be presented at the ASCO GI Symposium in January 2025. Looking ahead, Oncolytics Biotech will present at the Biotech Showcase on January 13, 2025, and host investor meetings during the J.P. Morgan Healthcare Conference that same week. These events will provide a platform to highlight its clinical advancements and reinforce its commitment to addressing critical unmet needs in oncology. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Erasca, Inc. (NASDAQ: ERAS), a clinical-stage precision oncology company, recently provided updates on its R&D advancements targeting RAS/MAPK pathway-driven cancers. In October 2024, the company presented promising Phase 1b SEACRAFT-1 data for naporafenib plus trametinib (MEKINIST®), showing potential for an NRAS-mutated melanoma indication and supporting the ongoing Phase 3 SEACRAFT-2 trial. Erasca also announced progress on its pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 programs, confirming best-in-class potential and preparing for IND submissions in 2025. Key milestones include data from SEACRAFT-2 in 2025 and initial Phase 1 monotherapy data for ERAS-0015 and ERAS-4001 in 2026. "We made significant progress across our pipeline programs and are pleased with the pace of our execution," said Jonathan E. Lim, M.D., Chairman, CEO, and co-founder of Erasca. "Positive preliminary data from SEACRAFT-1, which we reported at the 36th EORTC-NCI-AACR (ENA) Symposium last month, has refined our clinical development focus of naporafenib plus trametinib on patients with NRAS-mutant (NRASm) melanoma, and importantly, heightens our conviction in the ongoing SEACRAFT-2 registrational trial targeting a similar patient population. SEACRAFT-2 has the potential for approval based on the high unmet need of these patients as well as the alignment with US and European regulators on the NRASm melanoma indication. We expect randomized dose optimization data from Stage 1 of this Phase 3 trial in 2025." Allogene Therapeutics, Inc. (NASDAQ: ALLO), a clinical-stage biotechnology company, recently announced new data from the Phase 1 TRAVERSE trial evaluating ALLO-316, its first AlloCAR T™ product candidate, for advanced or metastatic renal cell carcinoma (RCC). Presented at the 2024 IKCS and SITC Annual Meetings, the data demonstrated a 50% overall response rate (ORR) and a 33% confirmed response rate (CRR) in patients with CD70 Tumor Proportion Scores (TPS) ≥50%. ALLO-316 showed robust CAR T cell expansion, manageable safety, and durable tumor responses, supporting the FDA's RMAT designation for advanced RCC. Additional data from the ongoing Phase 1b expansion cohort is expected in mid-2025. "ALLO-316, the leading "off-the-shelf" CAR T product candidate currently in development for solid tumors, continues to show remarkable potency in the TRAVERSE trial," said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer of Allogene. "Data from the Phase 1 study demonstrating significant anti-tumor activity in patients with metastatic disease resistant to multiple therapeutic classes, even with standard lymphodepletion, potentially marks a major advancement in the field. The unprecedented cell expansion and persistence driven by CD70 CAR-intrinsic Dagger® technology, along with strong evidence of tumor infiltration by CAR T cells, highlights the distinctive features of ALLO-316. We believe these findings from our Phase 1 trial lay the groundwork for a new generation of allogeneic cell therapies." Context Therapeutics Inc. (NASDAQ: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, recently announced advancements in its T cell-engaging bispecific antibody pipeline, including CT-202, a Nectin-4 x CD3 antibody licensed in September 2024, with an IND filing expected in mid-2026. Context also acquired CT-95, a Mesothelin x CD3 antibody, set to begin Phase 1 trials in Q1 2025. Additionally, Context will present data on its Claudin 6-targeting antibody CTIM-76 at the SITC Annual Meeting. " Context executed on its strategy to build a pipeline of T cell engaging bispecific antibodies through its acquisitions of CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody," said Martin Lehr, CEO of Context. "We continue to activate additional sites for our Phase 1 trial for CTIM-76, a Claudin 6 x CD3 bispecific antibody, and expect to dose our first patient by the end of this year. We also expect to advance CT-95 into the clinic soon and expect to enroll our first patient in our CT-95 Phase 1 study in the first quarter of 2025." Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX), a clinical stage TechBio company, recently announced interim data from the Phase 1/2 ELUCIDATE trial of REC-617, a selective CDK7 inhibitor, in advanced solid tumors. The trial showed REC-617 was well-tolerated with no discontinuations due to adverse events, and one patient with platinum-resistant ovarian cancer achieved a confirmed partial response lasting over six months, while four others had stable disease for up to six months. With plans to continue dose escalation and initiate combination studies in early 2025, REC-617 demonstrates potential as a safe and effective therapy in heavily pre-treated cancer patients. "Cell cycle dysregulation and transcriptional 'addiction' are both hallmarks of many aggressive cancers," said David Hallett, Ph.D., Chief Scientific Officer of Recursion. "By inhibiting CDK7, we have the potential to target both mechanisms while fine tuning the therapeutic index. Using our precision design platform, we created a molecule with rapid oral absorption to reduce GI tissue exposure, a suitable half life to manage side effects, and target engagement covering the IC80 level." 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