Pirtobrutinib

A blockbuster AstraZeneca drug may now be used as an earlier treatment for mantle cell lymphoma, making it the first in its class approved as a first-line therapy for this rare and aggressive type of blood cancer. The FDA expanded approval of the drug, acalabrutinib, to include previously untreated MCL in adults who are also ineligible for a hematopoietic stem cell transplant that is a treatment option for younger patients. As a first-line therapy, the AstraZeneca drug must be used in combination with bendamustine and rituximab, a drug regimen often used for older MCL patients. The late Thursday regulatory decision also grants traditional approval to the drug as a single-agent treatment for adults whose MCL has received an earlier line of therapy. MCL is type of B cell non-Hodgkin lymphoma, a cancer of the lymphatic system. Chemotherapy is the standard treatment, but relapse is common. Acalabrutinib, marketed under the brand name Calquence, is a small molecule designed to block Bruton’s tyrosine kinase (BTK), an enzyme that promotes the proliferation and survival of malignant B cells. Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient Calquence, a twice-daily pill, initially won accelerated FDA approval in 2017 as a treatment for adults whose MCL has received at least one prior therapy. In 2019, the AstraZeneca drug’s label expanded to include chronic lymphocytic leukemia or small lymphocytic leukemia. Calquence is one of AstraZeneca’s top oncology products, accounting for $2.5 billion in revenue in 2023, up 25% from the prior year. The latest FDA approval for Calquence is based on the results of ECHO, a Phase 3 study that enrolled 598 patients age 65 and older with untreated MCL. These participants were randomly assigned to receive the study drug plus the bendamustine/rituximab regimen, or a placebo and bendamustine/rituximab. At a median follow-up of 49.8 months, clinical trial results showed longer progression-free survival that was statistically significant. Median progression-free survival was 66.4 months in the study drug arm versus 49.6 months in the comparator group. The Phase 3 data were presented last June during the annual meeting of the European Hematology Association in Madrid. “Managing this aggressive cancer requires maximizing efficacy while maintaining tolerability, especially for elderly patients,” Michael Wang, director of the Mantle Cell Lymphoma Program of Excellence at MD Anderson Cancer Center and principal investigator in the trial, said in a prepared statement included in AstraZeneca’s approval announcement. “Results from the pivotal ECHO trial highlight the promise of the acalabrutinib combination in defining a new standard of care, with today’s approval underscoring the transformative potential of this regimen as a first-line treatment for older patients with mantle cell lymphoma.” presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical Calquence’s new FDA approval makes it the first BTK inhibitor approved as a first-line MCL treatment. That gives the drug an edge over others in its class. Eli Lilly’s BTK inhibitor, Jaypirca, landed FDA approval in 2023 as a third-line treatment for MCL. Imbruvica, marketed by Johnson & Johnson and AbbVie, and Brukinsa, from BeiGene (which is changing its name to BeOne Medicines), are both approved as second-line treatments for MCL.

SAN FRANCISCO and SUZHOU, China, Jan. 15, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343, a potentially best-in-class TOPO1i anti-CLDN18.2 ADC, as monotherapy for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients who have progressed after at least one line of prior systematic treatment. The BTD for IBI343 was granted based on data from an ongoing Phase 1 study conducted in China, Australia and the U.S. (NCT05458219), which demonstrated favorable safety and tolerability, as well as promising antitumor activity of IBI343 monotherapy in advanced PDAC patients. Data from the study's dose-expansion cohort were presented orally at the 2024 ESMO Asia Congress: A total of 43 patients with CLDN18.2-positive advanced PDAC (≥60% tumor cells with membranous staining intensity ≥1+ by IHC) received IBI343 6 mg/kg Q3W monotherapy. All participants had previously received at least one line of prior therapy, and 60.5% had received two or more lines of anticancer treatment. The confirmed overall objective response rate (ORR) was 23.3%, and progression-free survival (PFS) events occurred in 26 patients, with a median progression-free survival (mPFS) of 5.3 months (4.1-7.4) as of the data cutoff date. (link) Previously, in May 2024, the CDE has granted IBI343 its first BTD for monotherapy in the treatment of CLDN18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who have progressed after at least two lines of prior systematic treatments. In addition, in June 2024, IBI343 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, unresectable or metastatic PDAC that has relapsed and/or is refractory to one prior line of therapy. The first patient in the U.S. Phase 1 study of IBI343 was successfully dosed in December 2024. Dr. Hui Zhou, Senior Vice President of Innovent, said, "Pancreatic cancer is an aggressive and difficult-to-diagnose malignancy. At present, treatment for advanced pancreatic cancer relies primarily on systemic chemotherapy, with particularly limited options for second-line treatment. This results in poor patient outcomes and underscores an urgent unmet clinical need. As the world's first CLDN18.2 ADC to receive BTD in this difficult-to-treat cancer, IBI343 monotherapy has shown encouraging efficacy and tolerable safety in late-line treatment of patients with advanced pancreatic cancer. Subject to PoC data readout, we plan to initiate pivotal MRCT studies to further confirm its efficacy and safety in this indication. Additionally, we will also explore the potential of IBI343 in combination therapy for pancreatic cancer and other solid tumors, including gastric cancer." NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly. About Pancreatic Ductal Adenocarcinoma Pancreatic cancer is one of the most aggressive malignances of the digestive system, with a 5-year survival rate of about 10%[i]. Despite rising incidence rates in recent years, early detection remains low, seriously endangering human life and health. Current treatment for advanced pancreatic cancer is primarily based on systemic chemotherapy, with first-line treatment options typically including fluorouracil (5-FU) or gemcitabine-based chemotherapy. However, second-line treatment options are limited, offering a chemotherapy response rate of only 6-16%, a median progression free survival of 2 to 5 months, and a median overall survival of approximately 6 to 9 months[ii]. These statistics highlight the urgent need for new therapeutic approaches. Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally confined to the gastric mucosa. The development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[iii]. CLDN18.2 is present in 50% to 70% of pancreatic cancer cases, making it a highly targeted biomarker for therapeutic development[iv]. About IBI343 (CLDN18.2 ADC) IBI343 is an antibody-drug conjugate composed of an anti-CLDN18.2 antibody, and a cytotoxic drug exatecan. Binding of IBI343 to CLDN18.2-expressing tumor cells results in CLDN18.2-dependent internalization of IBI343. Degradation of the cleavable linker will release the drug that causes DNA damage, leading to apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring tumor cells, resulting in a strong "bystander killing effect" of IBI343. As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancers, including a Phase 3 trial (NCT06238843) for GC and a multi-regional Phase 1 trial (NCT05458219) for PDAC ongoing. IBI343 was granted breakthrough therapy designation (BTD) by China's National Medical Products Administration (NMPA) for two indications, as monotherapy in patients with CLDN18.2–positive GC who progressed after two prior lines of systemic treatment, and in patients with CLDN18.2-positive PDAC who have progressed after at least one line of prior systematic treatment. IBI343 also received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic PDAC that has relapsed and/or is refractory to one prior line of therapy. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 13 products in the market. It has 4 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza), Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. 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