U.S. FDA Accepts Regulatory Submission for Sintilimab in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous Non-Small Cell Lung Canc
SAN FRANCISCO?and SUZHOU,?China,?May 18, 2021?/PRNewswire/ --?Innovent Biologics, Inc. (HKEX: 01801) and Eli Lilly and Company (NYSE:?LLY) today jointly announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA)?for?sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC). This is the first U.S. regulatory submission of sintilimab, a PD-1 inhibitor being developed and commercialized under a global collaboration agreement between Innovent and Lilly.
"The acceptance of this application ? the first for sintilimab in the U.S. and outside of?China?? is an important milestone in Innovent's global commercialization strategy and in our collaboration with Lilly," said Dr.?Yongjun Liu, president of Innovent. "We look forward to working closely with the FDA to potentially bring this sintilimab-pemetrexed-platinum chemotherapy combination as a treatment option in the U.S., following the regimen's regulatory approval in?China?earlier this year."
Sintilimab is currently being evaluated in a wide variety of cancer types under a broad clinical development program. To date, sintilimab has two indications approved in?China, three regulatory submissions under review in?China, and this regulatory application under review in U.S.. This regulatory application was submitted to the FDA in?March 2021, primarily based on the results of the Phase 3 ORIENT-11 trial. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA to make a decision on the sintilimab application is in?March 2022. The FDA stated that it did not identify any potential review issues in its acceptance letter. It is currently planning to hold an Advisory Committee meeting to discuss this application.
"We are pleased the sintilimab submission is progressing. Our pursuit of this proposed indication in the U.S. reinforces Lilly's and Innovent's joint commitment to offer?additional?therapeutic options for people living with lung cancer and the healthcare providers who treat them," said?Anne White, president,?Lilly Oncology. "This is an encouraging start for our collaborative efforts to make sintilimab available in countries beyond?China, as we continue to pursue opportunities globally for this immuno-oncology medicine across various tumor types."
About the ORIENT-11 Trial
ORIENT-11?is a randomized, double-blind, Phase 3 clinical trial 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 (NSCLC), 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) and safety profile.
A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab 200mg or placebo in combination with pemetrexed and platinum chemotherapy every?three weeks for up to?four cycles, followed by either sintilimab 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 2020.1
About?Lung Cancer
Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year.?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.?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. Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.
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 for:
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about sintilimab injection in combination with pemetrexed and platinum chemotherapy as a potential first-line treatment of people with nonsquamous non-small cell lung cancer and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study results to date, or that sintilimab will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
[1] Yang Y, Wang Z, Fang J, Yu Q, Han B, Cang S, Chen G, Mei X, Yang Z, Ma R, Bi M, Ren X, Zhou J, Li B, Song Y, Feng J, Li J, He Z, Zhou R, Li W, Lu Y, Wang Y, Wang L, Yang N, Zhang Y, Yu Z, Zhao Y, Xie C, Cheng Y, Zhou H, Wang S, Zhu D, Zhang W, Zhang L. Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11). J Thorac Oncol. 2020 Oct;15(10):1636-1646. doi: 10.1016/j.jtho.2020.07.014. Epub 2020?Aug 8. SOURCE Innovent Biologics, Inc.
- 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 nonsquamous 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 BYVASDA? (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
- The second-line treatment of squamous non-small cell lung cancer
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about sintilimab injection in combination with pemetrexed and platinum chemotherapy as a potential first-line treatment of people with nonsquamous non-small cell lung cancer and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study results to date, or that sintilimab will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
[1] Yang Y, Wang Z, Fang J, Yu Q, Han B, Cang S, Chen G, Mei X, Yang Z, Ma R, Bi M, Ren X, Zhou J, Li B, Song Y, Feng J, Li J, He Z, Zhou R, Li W, Lu Y, Wang Y, Wang L, Yang N, Zhang Y, Yu Z, Zhao Y, Xie C, Cheng Y, Zhou H, Wang S, Zhu D, Zhang W, Zhang L. Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11). J Thorac Oncol. 2020 Oct;15(10):1636-1646. doi: 10.1016/j.jtho.2020.07.014. Epub 2020?Aug 8. SOURCE Innovent Biologics, Inc.