Innovent Announces NMPA's Breakthrough Therapy Designation for IBI351 (KRAS G12C Inhibitor) as Monotherapy for Previous Treated Advanced Non-small Cell Lung Cancer

Rhea-AI Summary

Innovent Biologics announced that the NMPA in China has granted Breakthrough Therapy Designation (BTD) for IBI351, a KRAS^G12C inhibitor, aimed at treating advanced non-small cell lung cancer (NSCLC). This designation is based on positive Phase I/II trial results showing a 50.9% objective response rate (ORR) and a 92.7% disease control rate (DCR) in evaluable NSCLC patients. The drug exhibited a favorable safety profile, with 92.5% experiencing treatment-related adverse effects primarily at manageable grades. Ongoing trials aim to confirm its efficacy in this challenging patient population.

Positive

• Breakthrough Therapy Designation granted by NMPA for IBI351, indicating significant potential for expedited development.
• Phase I/II trial results show 50.9% ORR and 92.7% DCR among evaluable NSCLC patients.
• IBI351 demonstrated favorable safety profile with no dose-limiting toxicities reported.

Negative

• Limited treatment options for KRAS^G12C mutated NSCLC patients may indicate high unmet medical need.
• No median duration of response (DOR) or progression-free survival (PFS) data available yet.

ROCKVILLE, Md. and SUZHOU, China, Jan. 4, 2023 /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, autoimmune, metabolic, 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 IBI351 (GFH925)  for the treatment of advanced non-small cell lung cancer patients with KRAS^G12C mutation that have received at least one prior line of systemic therapy.

The NMPA BTD for IBI351 was based on the results from a phase I/II trial (CDE Registration No. CTR20211933). This study aims to evaluate the safety, tolerability and efficacy of IBI351 monotherapy in patients with advanced solid tumors who failed or intolerant to standard of care treatment.

The latest results of IBI351 from the phase I study were presented at the 2022 Chinese Society of Clinical Oncology (CSCO) Annual Meeting. As data cutoff (29 July 2022), of 55 evaluable NSCLC patients, the investigator assessed objective response rate (ORR) was 50.9% and disease control rate (DCR) was 92.7%. Of 21 patients with NSCLC treated at 600mg BID (the recommended phase 2 dose), better efficacy signal was observed, with investigator assessed ORR 61.9% and DCR 100%. Median duration of response (DOR) and median progression free survival (PFS) were not reached yet.

As data cutoff date, IBI351 was well tolerated. No DLT was reported and MTD was not reached. Treatment-related adverse events (TRAEs) occurred in 92.5% (62/67) patients and the most common TRAEs were anemia, transferase increased, bilirubin increased, pruritus and fatigue. The majority of the TRAEs were grade 1-2 with 19.4% (13/67) of patients reporting grade 3 or higher TRAEs. There were no grade 5 TRAEs or TRAEs led to treatment discontinuation.

Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed. The single-arm registrational trial of IBI351 monotherapy in previously-treated advanced non-small cell lung cancer patients with KRAS^G12C mutation is ongoing. Relevant updated study results will be published at an upcoming medical conference in 2023.

"We are glad to see the NMPA grants Breakthrough Therapy Designation based on the results of Phase I data of IBI351," said Dr. Hui Zhou, Senior Vice President of Innovent. "KRAS^G12C mutated NSCLC patients have limited treatment options. IBI351 demonstrated encouraging efficacy and safety data in Phase I study. A single arm registrational trial of IBI351 monotherapy in previously-treated advanced NSCLC is ongoing.  We are working to advance into late stage clinical development to explore the potential of IBI351 as monotherapy and in combo-therapy."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace. Click here for the published list of drugs which have been granted BTD by NMPA.

About Non-small Cell Lung Cancer

Lung cancer is one of the malignancies with the highest incidence and mortality worldwide, among which non-small cell lung cancer (NSCLC) is the most common pathological type, accounting for about 85% of all lung cancers.  KRAS mutations are common driver gene mutations in NSCLC, most of which occur in lung adenocarcinoma.  KRAS mutations rarely co-exist with driver mutations such as EGFR and ALK, and patients with advanced NSCLC with KRAS^G12C mutations are often unable to benefit from the multiple drugs already on the market that target these mutations or rearrangements. After the progress of first-line standard treatment in this population, there are limited second-line treatment options with low effective rate and poor prognosis. 

About IBI351/GFH925(KRAS^G12C Inhibitor)

Discovered by GenFleet Therapeutics, GFH925 (Innovent R&D code: IBI351) is a novel, orally active, potent KRAS^G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS^G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of IBI351 towards KRAS^G12C. Subsequently, IBI351 effectively inhibits the downstream signal pathway to induce tumor cells' apoptosis and cell cycle arrest.

In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of IBI351 in China (including mainland China, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. 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.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 36 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include:  TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI) , Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 2 assets are under NMPA NDA review, 6 assets are in Phase 3 or pivotal clinical trials, and 20 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

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.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
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:

1. This indication is still under clinical study, which hasn't been approved in China.
2. 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.

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SOURCE Innovent Biologics

FAQ

What is the significance of Innovent Biologics receiving Breakthrough Therapy Designation for IBI351?

It allows for expedited development and review of IBI351 for treating advanced NSCLC patients, facilitating quicker access to the drug.

What are the results of the Phase I/II trial for IBI351 in treating NSCLC?

The trial showed a 50.9% objective response rate (ORR) and a 92.7% disease control rate (DCR) among evaluable patients.

How does IBI351 perform regarding safety in its clinical trials?

IBI351 showed a favorable safety profile with 92.5% of patients experiencing treatment-related adverse effects primarily at manageable grades.

What does the Breakthrough Therapy Designation imply for IBI351's future?

This designation implies that IBI351 has demonstrated substantial improvement over current therapies, allowing for rapid review and potential faster approval.

What is the status of further studies for IBI351?

A single-arm registrational trial for IBI351 in previously-treated advanced NSCLC patients is ongoing, with updated results expected in 2023.