Innovent Biologics, Inc. – a leading global biopharmaceutical company – has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for its IBI351 (GFH925) therapy, to treat advanced non-small cell lung cancer patients with KRASG12C mutation that have previously received at least one line of systemic therapy. This breakthrough therapy is set to improve the quality of life for many suffering from this illness.
The NMPA BTD for IBI351 was based on findings from a groundbreaking clinical trial (CDE Registration No. CTR20211933). This pivotal study seeks to assess the safety, tolerability, and effectiveness of IBI351 monotherapy as a treatment option for advanced solid tumors in patients who have failed or are unable to tolerate traditional therapies.
At the 2022 Chinese Society of Clinical Oncology (CSCO) Annual Meeting, IBI351 presented the latest results of their Phase I study. The study included 55 evaluable non-small cell lung cancer (NSCLC) patients, with an investigator-assessed objective response rate (ORR) of 50.9% and disease control rate (DCR) of 92.7%. Patients treated with 600mg BID (the recommended phase 2 dose) showed even more promising results, with an ORR of 61.9% and DCR of 100%. The median duration of response (DOR) and median progression free survival (PFS) had yet to be reached at the data cutoff of 29 July 2022.
As data cutoff date, IBI351 was found to be well-tolerated with no DLT reported, and MTD was not reached. Of the 67 patients, 92.5% (62/67) experienced treatment-related adverse events (TRAEs), the most common being anemia, transferase increase, bilirubin increase, pruritus, and fatigue. Fortunately, the majority of TRAEs were mild at grade 1-2, with only 19.4% (13/67) developing grade 3 or higher. Thankfully, there were no grade 5 TRAEs or TRAEs that led to treatment discontinuation.
IBI351 monotherapy has shown promising antitumor activity with a favorable safety and tolerability profile. A registrational trial of IBI351 as a monotherapy for previously-treated advanced non-small cell lung cancer patients with the KRASG12C mutation is currently underway. Results from this study are expected to be presented at a medical conference in 2023, offering a glimpse into the potential of this novel therapy.
“We are thrilled that the NMPA has granted Breakthrough Therapy Designation to IBI351, based on the promising results of our Phase I trial,” said Dr. Hui Zhou, Senior Vice President of Innovent. “KRASG12C mutated NSCLC patients are in desperate need of more treatment options, and IBI351 is showing early signs of both efficacy and safety. We are currently conducting a single arm registrational trial of IBI351 monotherapy in previously-treated advanced NSCLC and are committed to advancing it through late stage clinical development to explore its potential as both monotherapy and in combination with other therapies.”
The NMPA Breakthrough Therapy Designation is a pathway to expediting the development and review of a promising drug that could potentially provide a substantial improvement over current therapies for serious diseases or conditions. This designation offers sponsors the opportunity to receive faster review and approval from the CDE, as well as timely advice and communication, so that patients with unmet clinical needs can benefit from the treatment as soon as possible. Already, a number of drugs have been granted the Breakthrough Therapy Designation. Click here to view the full list.
About Non-small Cell Lung Cancer
Lung cancer, with its high incidence and mortality worldwide, is one of the deadliest malignancies. Non-small cell lung cancer (NSCLC) is the most common type, making up 85% of all lung cancers. KRAS mutations are common in NSCLC, particularly in lung adenocarcinoma, and rarely co-exist with other driver gene mutations. Unfortunately, patients with advanced NSCLC and KRASG12C mutations are unable to benefit from treatments targeting EGFR and ALK mutations. Even after first-line standard treatment, there are only limited second-line options with low effectiveness and poor prognosis.
About IBI351/GFH925(KRASG12C Inhibitor)
Introducing GFH925 (IBI351), a revolutionary new drug from GenFleet Therapeutics. This orally active, potent KRASG12C inhibitor is designed to directly target the GTP/GDP exchange – a vital step in pathway activation – by covalently and irreversibly modifying the cysteine residue of the KRASG12C protein. Preclinical testing showed that IBI351 offers exceptional selectivity for KRASG12C, inhibiting downstream signal pathways to effectively induce tumor cell apoptosis and cell cycle arrest. This groundbreaking drug has the potential to revolutionize cancer treatment!
In a groundbreaking move, Innovent and GenFleet Therapeutics have agreed on an exclusive license agreement to develop and commercialize IBI351 in China, including mainland China, Hong Kong, Macau and Taiwan, as well as global development and commercialization options. This monumental agreement was reached in September 2021.
Innovent is an innovator in the biopharmaceutical industry, driven by a commitment to make high-quality treatments for cancer, autoimmune disease, metabolic disorder and other major diseases accessible to everyone. Since our founding in 2011, we have achieved remarkable success and, on October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Guided by the mantra “Start with Integrity, Succeed through Action,” Innovent is committed to developing and commercializing groundbreaking treatments that make a real difference to people’s lives.
Innovent has built a groundbreaking multi-functional platform, which has enabled the development of a robust pipeline of 36 assets in key therapeutic areas such as cancer, metabolic disorder, and autoimmune disease. 8 of its products have already been approved by the NMPA, with 2 more undergoing NDA review. Furthermore, 6 assets are in Phase 3 or pivotal clinical trials, and 20 molecules are in clinical studies. Among these are TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, Pemazyre®, olverembatinib, Cyramza®, and Retsevmo®. The company is actively working to develop more powerful and effective treatments to improve the quality of life for patients.
Innovent has assembled an elite global team of experts in high-end biological drug development and commercialization to make a lasting impact in the biopharmaceutical industry. To further their mission, Innovent has partnered with esteemed companies such as Eli Lilly and Company, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center to help bring advanced drugs to the market and improve the quality of life for patients.
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