FDA Advisory Committee Votes to Recommend Additional Data for Sintilimab Submission
The FDA's Oncology Drug Advisory Committee voted for additional clinical trials for sintilimab, an investigational PD-1 inhibitor, before considering its first-line treatment application for non-squamous non-small cell lung cancer (nsqNSCLC) based on the ORIENT-11 trial conducted in China. The committee highlighted a need for data validating the drug's applicability to the U.S. population. Innovent and Lilly, who are collaborating on sintilimab, acknowledged the disappointment but remain optimistic about its potential and will continue working with the FDA.
- Sintilimab was evaluated in the ORIENT-11 trial, demonstrating a positive risk and benefit profile according to Innovent.
- Sintilimab is already approved in China for multiple indications, enhancing its market position.
- FDA committee's requirement for additional trials may delay the approval process for sintilimab in the U.S.
- The need for further data may indicate uncertainties surrounding the drug's applicability to the U.S. market.
SAN FRANCISCO, and SUZHOU, China, Feb. 10, 2022 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) held a public Oncology Drug Advisory Committee (ODAC) for sintilimab, which is under review for the first-line treatment of people with non-squamous non-small cell lung cancer (nsqNSCLC) based on the ORIENT-11 trial conducted exclusively in China. On the single voting question, the advisory committee voted that additional clinical trial(s) should be required to demonstrate applicability to the U.S. population and U.S. medical practice prior to a final regulatory decision. Sintilimab is a novel PD-1 inhibitor being developed and commercialized under a collaboration agreement between Innovent and Lilly.
"We appreciate this opportunity to share our data of ORIENT-11 with FDA and the advisory committee. While conducted in China, ORIENT-11 was well designed and conducted in compliance with ICH GCP standards. The data of sintilimab generated from ORIENT-11 has suggested a positive risk and benefit profile, with no safety issue identified by the FDA." said Dr. Yongjun Liu, President of Innovent. "While we are disappointed by the ODAC outcome, we together with Lilly will continue to work with FDA as the agency completes its review of our BLA application. We remain confident in the value of sintilimab, and the interaction with FDA will help us to pave the way to advance our exciting pipeline and globally develop innovative medicines for patients around the world."
"While we are disappointed with the outcome of today's ODAC as it relates to the investigational product sintilimab, we appreciated the opportunity to publicly discuss the application and broader issues related to single-country clinical trials," said Jacob Van Naarden, President, Lilly Oncology. "Along with Innovent, we will continue to work with the FDA as it completes its review of the sintilimab application."
The ODAC provides the FDA with independent advice and recommendations from outside experts on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the vote as it reviews the application and is not bound by the committee's guidance. Innovent and Lilly will continue to work closely with the agency as they complete their review of the application.
About the ORIENT-11 Trial
ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial conducted in China assessing the efficacy and safety of sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC), with no sensitizing EGFR mutations or ALK rearrangements. The primary endpoint is progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1., and secondary endpoints include overall survival (OS), ORR and safety profile.
A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab injection 200mg or placebo in combination with pemetrexed and platinum chemotherapy every three weeks for up to four cycles, followed by either sintilimab injection or placebo plus pemetrexed maintenance therapy. Patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Conditional crossover was permitted. The results of the ORIENT-11 study were published in 2020.
About Lung Cancer
Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year.[i] In the U.S., lung cancer is the second most common cancer (not counting skin cancer) and the leading cause of cancer death, responsible for nearly 25 percent of all cancer deaths – more than those from colorectal, breast and prostate cancers combined.[ii] Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers, and about 70 percent of those with NSCLC have the nonsquamous subtype.[iii] Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.[iv]
About Sintilimab
Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. 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. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.
In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including:
- The treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy;
- In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer;
- In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer;
- In combination with bevacizumab biosimilar for the first-line treatment of unresectable or advanced hepatocellular carcinoma.
Additionally, Innovent currently has three regulatory submissions under review in China's NMPA for sintilimab:
- In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma;
- In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
- In combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.
Additionally, two clinical studies of sintilimab have met their primary endpoints:
- Phase 2 study as second-line treatment of esophageal squamous cell carcinoma;
- Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.
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, metabolic 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 29 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 6 products, TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection),PEMAZYRE® (pemigatinib) and Olverematinib (BCR TKI) officially approved for marketing in China, 5 assets in Phase 3 or pivotal clinical trials, and additional 18 molecules in clinical trials.
Innovent has built an international team of talented professionals in biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people 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.
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 materialise or turn out to be incorrect.
[i] International Agency for Research on Cancer. 2018 Lung Cancer Fact Sheet. Available at: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed January 18, 2022. |
[ii] American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed January 18, 2022. |
[iii] American Cancer Society. What is non-small cell lung cancer? Available at: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Accessed January 18, 2022. |
[iv] Riess, J. Shifting Paradigms in Non-Small Cell Lung Cancer: An Evolving Therapeutic Landscape Supplement. Am J Manag Care. 2013;19:S390-S397. |
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SOURCE Innovent Biologics
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