ELI LILLY AND COMPANY

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Innovent Biologics, Inc. and Eli Lilly and Company Jointly Announces Approval of TYVYT by China NMPA in Combination with Chemotherapy as First-Line Treatment of Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

06/27/2022 EDT

Innovent Biologics, Inc. and Eli Lilly and Company announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. This is the sixth NMPA-approved indication of TYVYT®. TYVYT® is the first domestic PD-1 inhibitor approved for the first-line treatment of gastric cancer and is currently approved for the first-line treatment in five major types of cancers.

In China, TYVYT® was approved for the treatment of relapsed or refractory classical Hodgkin's lymphoma in December 2018, first-line treatment of nonsquamous non-small cell lung cancer (NSCLC) in February 2021, first-line treatment of squamous NSCLC, and the first-line treatment of hepatocellular carcinoma in June 2021; and the first-line treatment of esophageal squamous cell carcinoma in June 2022. The approval in China was based on the results of a randomized, double-blind, multicenter Phase III clinical trial (ORIENT-16, NCT03745170) evaluating sintilimab in combination with chemotherapy (oxaliplatin and capecitabine), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Based on the interim analysis by Independent Data Monitoring Committee (iDMC), sintilimab in combination with chemotherapy demonstrated superior overall survival (OS), compared to placebo plus chemotherapy, with a 34.0% reduction in the risk of death (HR 0.660,95% CI 0.505-0.864,p=0.0023) and a 5.5-month improvement in median OS (mOS 18.4 months vs.

12.9 months) in patients with combined positive score (CPS) =5, and 23.4% reduction in the risk of death (HR 0.766, 95%CI 0.626-0.936,p=0.0090)and a 2.9-month improvement in mOS (15.2 months vs. 12.3 months) in all patients regardless of PD-L1 expression. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified for the combination of sintilimab and chemotherapy.

The results of ORIENT-16 study were presented at the European Society for Medical Oncology (ESMO) Congress 2021[1]. ORIENT-16 is a randomized, double-blind, multi-center Phase 3 clinical study evaluating sintilimab or placebo, in combination with chemotherapy (oxaliplatin and capecitabine), for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ClinicalTrials.gov, NCT03745170). The primary endpoint was overall survival, in PD-L1 positive (CPS>5) and all randomized patients.

As of the cutoff date for the interim analysis, a total of 650 patients were enrolled and randomly assigned with a 1:1 ratio to receive sintilimab or placebo in combination with chemotherapy until disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. The study met both primary endpoints and the safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified for the combination of sintilimab and chemotherapy. The results were published at the ESMO Congress 2021.


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Sales 2022 28 860 M - -
Net income 2022 6 375 M - -
Net Debt 2022 9 953 M - -
P/E ratio 2022 45,5x
Yield 2022 1,21%
Capitalization 307 B 307 B -
EV / Sales 2022 11,0x
EV / Sales 2023 10,3x
Nbr of Employees 35 000
Free-Float 99,7%
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