Selpercatinib

SAN FRANCISCO and SUZHOU, China, June 2, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, announced that the clinical data of a randomized controlled Phase 1b study evaluating IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab as neoadjuvant treatment of colon cancer was orally presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (ClinicalTrials.gov, NCT05890742). The abstract was selected for ASCO Daily News coverage. Based on the promising Phase 1b results, Innovent has opened the Phase 3 trial (Neoshot) evaluating IBI310 in combination with sintilimab as neoadjuvant treatment of colon cancer. The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has also granted Breakthrough Therapy Designation (BTD) for IBI310. Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: results from a randomized, open-labeled, Phase 1b study Abstract #: 3505 In this Phase 1b study, the efficacy and safety of IBI310 in combination with sintilimab versus sintilimab as neoadjuvant therapy for resectable stage IIB-III MSI-H/dMMR colon cancer was evaluated. As of February 4, 2024, 101 pts were enrolled and randomized to receive IBI310 plus sintilimab (n=52) or sintilimab alone (n=49). For per-protocol set, the pathologic complete response (pCR) rates in IBI310 plus sintilimab arm were significantly improved than sintilimab alone arm （ 80.0% vs 47.7%, p=0.0007 ） . Treatment related adverse events (TRAEs) leading to surgery delay occurred in 2 pts (3.8%) in IBI310 plus sintilimab arm and 0 pt in sintilimab alone arm. Grade ≥3 immune-related adverse events (irAEs) occurred in 3 pts (5.8%) and in 4 pts (8.2%), respectively. IBI310 plus sintilimab did not increase safety risk compared to sintilimab alone, and did not affect the subsequent surgery. The Principal Investigator of the study, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated, "At present, complete (R0) resection for some stage IIB-III colon cancer patients remain a significant challenge, along with risks of extensive trauma and poor prognosis. In particular, neoadjuvant chemotherapy is not effective in MSI-H/dMMR colon cancer, and the pCR rate is only about 5%[1]. This Phase 1b study was the first randomized study to demonstrate the significant higher pCR rate of the dual immunotherapy in MSI-H/dMMR colon cancer. Neoadjuvant treatment of IBI310 in combination with sintilimab is potentially practice-changing that could reduce the preoperative staging, narrow the scope of radical resection, increase the complete resection rate, reduce the requirement of adjuvant chemotherapy and decrease the incidence of relapse, so as to improve the long-term prognosis and potentially cure the patients. The Phase 3 clinical study (Neoshot) is ongoing in China, and we look forward to positive results from this study to provide a more effective treatment option for patients with MSI-H/dMMR colon cancer." Dr. Hui Zhou, Senior Vice President of Innovent, stated, "There is a huge unmet clinical need for neoadjuvant therapy of resectable MSI-H/dMMR colon cancer in China. In this randomized, controlled Phase 1b study, IBI310 in combination with sintilimab significantly improved pCR rate than sintilimab alone in MSI-H/dMMR CRC with manageable safety profile. Based on the strong results of this study, we moved IBI310 in combination with sintilimab into Phase 3 trial (Neoshot) earlier this year, and we are looking forward to the positive results." About IBI310 IBI310 is a fully human monoclonal antibody injection independently developed by Innovent. IBI310 can specifically bind cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4 mediated T cell inhibition, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells[2]. In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Besides, the New Drug Application ("NDA") for the combination of sintilimab and fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR or non-MSI-H tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the NMPA. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 4 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States. Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Disclaimer: Innovent does not recommend any off-label usage. 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. References 1 2 Wang J, Fei K, Jing H, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. DOI: 10.1080/19420862.2019.1654303. SOURCE Innovent Biologics

The FDA on Wednesday granted Eli Lilly’s selective RET kinase inhibitor Retevmo (selpercatinib) accelerated approval to treat children two years and older with certain RET-mutated thyroid and solid tumours. According to the US regulator, it’s the first targeted cancer therapy for paediatric patients younger than 12 with RET alterations.Specifically, Retevmo was cleared for advanced or metastatic medullary thyroid cancer with a RET mutation; advanced or metastatic thyroid cancer with a RET gene fusion in patients who are radioactive iodine-refractory; and locally advanced or metastatic solid tumours with a RET gene fusion in patients who have progressed on a prior systemic therapy. The RET inhibitor already holds accelerated approval for the thyroid cancer indications in adults and paediatric patients older than 12, as well as the solid tumour indication in adults.Supporting dataThe new paediatric approval was based on results of the Phase I/II LIBRETTO-121 study in 25 patients ages 2 to 20 with locally advanced or metastatic RET-activated solid tumours non-responsive to available therapies.Retevmo led to a confirmed overall response rate (ORR) of 48%. Additionally, the median duration of response (DOR) was not reached, with 92% of responders still seeing a treatment effect at 12 months.The most common adverse reactions seen in more than a quarter of patients were musculoskeletal pain, diarrhoea, headache, nausea, vomiting and fatigue, among others.Lily gained Retevmo through its $8-billion acquisition of Loxo Oncology in 2019.