Atezolizumab

During Roche’s second-quarter earnings presentation last month, the company listed Tecentriq in ctDNA-positive high-risk muscle-invasive bladder cancer as one of its planned regulatory submissions in 2025.\n Roche has found redemption in a precision medicine approach following an earlier Tecentriq trial flop in a broader bladder cancer population.Tecentriq helped certain patients with muscle-invasive bladder cancer (MIBC) live longer compared with placebo when used after surgery, according to results from the phase 3 IMvigor011 trial. The PD-L1 inhibitor also outperformed placebo at preventing disease recurrence, metastasis or death on the study’s primary endpoint, disease-free survival.The comparison—and the administration of Tecentriq or placebo—was made in patients who tested positive for molecular residual disease (MRD) up to 12 months after surgery but stayed free of cancer recurrence on imaging. MRD measures small traces of remaining cancer cells that may not show up as tumors on imaging.Natera, which developed the circulating tumor DNA test to measure MRD, reported the news Monday. Roche, which sponsors the study, did not announce the readout in a press release. A spokesperson for Roche’s U.S. subsidiary, Genentech, confirmed the hit on both trial endpoints to Fierce Pharma and said data will be shared with the FDA and presented at an upcoming medical meeting. During Roche’s second-quarter earnings presentation last month, the company listed Tecentriq in ctDNA-positive high-risk MIBC as one of its planned regulatory submissions in 2025. The improvements by Tecentriq were “statistically significant and clinically meaningful,” according to Natera. The Texas-based company said it plans to finalize its application to the FDA for the ctDNA test, called Signatera, as a companion diagnostic for selecting MIBC patients who may receive Tecentriq as an adjuvant treatment after cystectomy.“The results of IMvigor011 are very significant, opening the door for a new treatment paradigm for bladder cancer patients who are positive for recurrence on a molecular level but have no evidence of disease on imaging,” the study’s lead investigator, Thomas Powles, M.D., from Britain’s Barts Cancer Institute, said in a statement Monday.The positive IMvigor011 readout from an MRD-selective population came more than five years after the IMvigor010 trial comparing adjuvant Tecentriq with simple observation in an unselective group of MIBC patients failed to meet its primary goal of disease-free survival. The MIBC landscape is no longer the same as it was five years ago. In March, the FDA approved AstraZeneca’s Imfinzi as the first immunotherapy for MIBC. The PD-L1 inhibitor nabbed a perioperative approval for use alongside chemotherapy before surgery and then on its own after surgery.The regimen mounted a statistically significant 25% reduction in the risk of death compared with neoadjuvant chemo alone followed by surgery, according to results from the phase 3 Niagara trial conducted in a biomarker-unrestricted patient population.What’s more, word came out last week that the combination of Pfizer and Astellas’ antibody-drug conjugate Padcev and Merck & Co.’s Keytruda also delivered an all-around perioperative win in patients with cisplatin-ineligible MIBC.

Patent Expiry and the Need for New Therapeutic Strategies Liminatus Pharma, Inc (NASDAQ:LIMN) LA PALMA, CA, UNITED STATES, August 18, 2025 / EINPresswire.com / -- PD-1/PD-L1 inhibitors such as Keytruda, Opdivo, Tecentriq, Imfinzi, and Libtayo have been standard-of-care treatments for multiple cancer indications since their approvals beginning in 2014. Key U.S. patents for these agents are projected to expire between 2028 and 2030. While the introduction of biosimilars may improve treatment accessibility, it also highlights the need for new therapeutic strategies—particularly combination regimens—that can deliver improved clinical outcomes and address patient populations with suboptimal responses to current therapies. Pharmaceutical development efforts are increasingly focused on combination approaches that can enhance efficacy, expand the range of responsive tumor types, and maintain relevance in an evolving treatment landscape. Scientific Rationale and Differentiation of IBA101 IBA101 is a next-generation CD47-blocking monoclonal antibody engineered to avoid binding to red blood cells and platelets, thereby reducing the risk of severe anemia and thrombocytopenia observed with earlier CD47 inhibitors. Mechanistically, IBA101 promotes innate immune activation, particularly macrophage-mediated phagocytosis of tumor cells. This leads to increased tumor antigen release and presentation, priming the adaptive immune system and generating tumor-specific T-cell responses. In contrast, PD-1/PD-L1 blockade primarily amplifies tumor-reactive T cells that are already present within the patient’s immune repertoire, enabling them to attack tumor cells. Although effective, this approach can be limited by tumor clonal heterogeneity: not all malignant clones express the same target antigens, allowing some tumor subpopulations to evade immune clearance and potentially cause relapse. By enhancing macrophage-mediated tumor antigen presentation, IBA101 has the potential to stimulate de novoT-cell responses against newly exposed tumor antigens. This continuous induction of T-cell immunity against evolving antigenic targets may help track and eliminate emerging tumor variants, reducing immune escape and potentially extending remission. Synergy with PD-1/PD-L1 Blockade The immunologic complementarity between CD47 blockade and PD-1/PD-L1 inhibition provides a strong rationale for combination therapy:  Upstream activation: IBA101 enhances antigen presentation and primes T cells through innate immune pathways.  Downstream release: PD-1/PD-L1 inhibitors relieve inhibitory signaling in these activated T cells, enabling sustained anti-tumor activity. Preclinical studies have shown that IBA101 combined with PD-1 blockade produces synergistic anti-tumor effects with a favorable safety profile. Planned clinical trials aim to determine whether this combination can improve objective response rates, depth of response, and durability compared to PD-1/PD-L1 monotherapy, particularly in patient groups with limited benefit from existing therapies. Outlook Ongoing research will clarify whether combining IBA101 with PD-1/PD-L1 blockade can address the challenge of tumor heterogeneity and expand the therapeutic reach of checkpoint inhibitors. These investigations are intended to generate robust clinical evidence to guide future treatment strategies in oncology. About Liminatus Pharma Liminatus Pharma (Nasdaq: LIMN) is a preclinical-stage immuno-oncology company advancing IBA101 toward best-in-human trials. Building on over a decade of CD47 research and lessons learned from industry setbacks, Liminatus’s mission is to develop next-generation immunotherapies that restore immune balance—bridging innate and adaptive immunity to drive safer, more durable anti-tumor responses. Forward-Looking Statements Cautionary Note Regarding Forward-Looking Statements Statements in this press release may constitute "forward-looking statements" under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of present or historical fact, that address activities, events or developments that Liminatus Pharma, Inc. expects, believes or anticipates will or may occur in the future, including statements about results of operations and financial condition, expected future results, expected benefits from our investment and strategic plans and other initiatives, and expected future growth and profitability, are forward-looking statements. The words "will," "may," "believes," "anticipates," "thinks," "expects," "estimates," "plans," "intends" and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated by these forward-looking statements. In addition, statements which refer to expectations, projections or other characterizations of future events or circumstances, statements involving a discussion of strategy, plans or intentions, statements about management's assumptions, projections or predictions of future events or market outlook and any other statement other than a statement of present or historical fact are forward-looking statements. For more information, please contact: Chris Kim, Chief Executive Officer info@liminatuspharma.com 213-273-5453 www.liminatuspharma.com Chris Kim Liminatus Pharma, Inc +1 213-273-5453 Chris@liminatus.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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