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    1801   KYG4818G1010

INNOVENT BIOLOGICS, INC.

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Innovent Announces ORIENT-31, a Phase 3 Study of Sintilimab in Patients with EGFR-Mutated Nonsquamous Non-Small Cell Lung Cancer with Prior EGFR-TKI Treatment, Has Met Primary Endpoint

10/18/2021 EST

Innovent Biologics, Inc. announced that the sintilimab ORIENT-31 study has met its prespecified primary endpoint of progression-free survival (PFS) at the first interim analysis. Globally, ORIENT-31 is the first prospective, double-blind, multi-center, Phase 3 study that has demonstrated significant PFS improvement of anti-PD-1 and anti-VEGF antibody combination therapy (i.e., sintilimab plus BYVASDA® [bevacizumab biosimilar injection] combined with chemotherapy [pemetrexed and cisplatin]) in patients with epidermal growth factor receptor (EGFR)-mutated nonsquamous non-small cell lung cancer (nsqNSCLC) that has progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI). In the first interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), in the intent-to-treat (ITT) population, based on assessment by the Blinded Independent Radiographic Review Committee (BIRRC), sintilimab in combination with BYVASDA® (bevacizumab biosimilar injection) and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy. Sintilimab in combination with chemotherapy also showed a trend of PFS benefit compared to chemotherapy alone (data is not yet mature). Additionally, the prespecified PFS futility analysis that compares sintilimab in combination with BYVASDA® (bevacizumab biosimilar injection) and chemotherapy to sintilimab in combination with chemotherapy did not cross futility stopping boundary. A numerical benefit of adding BYVASDA® (bevacizumab biosimilar injection) to sintilimab and chemotherapy combination can be observed. The safety profile of this study was consistent with that observed in previously reported studies of sintilimab and BYVASDA® (bevacizumab biosimilar injection), with no additional safety signals. The detailed results of ORIENT-31 will be presented at an upcoming medical meeting. About Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Lung cancer is the leading cause of cancer death worldwide, and the second most commonly diagnosed tumor type. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of all lung cancer, in which about 70% of NSCLC patients present with locally advanced or metastatic disease that is not suitable for surgical resection at diagnosis. In China, nsqNSCLC accounts for 70% of NSCLC, in which about 40% to 50% of nsqNSCLC patients have an EGFR mutation. The standard first-line treatment for patients with advanced EGFR-mutated NSCLC is a third generation EGFR TKI, or first or second generation EGFR TKI. For patients who have progressed following EGFR-TKI treatment, platinum-based chemotherapy is still the standard therapy with limited benefit, representing a large unmet medical need. ORIENT-31 is a randomized, double-blind, multicenter Phase 3 clinical study evaluating sintilimab, with or without BYVASDA® (bevacizumab biosimilar injection), combined with chemotherapy (pemetrexed and cisplatin) in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed following EGFR TKI treatment (ClinicalTrials.gov, NCT003802240). The primary endpoint is PFS as assessed by BIRRC based on RECIST v1.1. The secondary endpoints include overall survival (OS), PFS as assessed by investigators, objective response rate (ORR) and safety. Eligible patients included: patients with disease progression following first or second generation EGFR TKI and confirmed as T790M negative, or T790M positive but further progressed on third generation EGFR-TKI treatment, or patients with disease progression following third generation EGFR-TKI as first line treatment. Patients were randomized in a 1:1:1 ratio to receive sintilimab plus BYVASDA® (bevacizumab biosimilar injection) combined with pemetrexed and cisplatin, sintilimab plus placebo 2 combined with pemetrexed and cisplatin, or placebo 1 plus placebo 2 combined with pemetrexed and cisplatin. After 4 cycles of combination treatment, patients will receive maintenance treatment of sintilimab plus BYVASDA® and pemetrexed, sintilimab plus placebo 2 and pemetrexed, placebo 1 plus placebo 2 and pemetrexed, until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Target accrual is 480 patients.


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Financials
Sales 2021 4 217 M 660 M 660 M
Net income 2021 -1 560 M -244 M -244 M
Net cash 2021 5 334 M 834 M 834 M
P/E ratio 2021 -55,9x
Yield 2021 -
Capitalization 87 944 M 13 756 M 13 758 M
EV / Sales 2021 19,6x
EV / Sales 2022 13,1x
Nbr of Employees 4 596
Free-Float 92,7%
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Number of Analysts 25
Last Close Price 60,25 CNY
Average target price 78,53 CNY
Spread / Average Target 30,3%
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Managers and Directors
De Chao Yu Chairman & Chief Executive Officer
Yong-Jun Liu President
Hao Xi Ede Chief Financial Officer & Executive Director
Jessie Chen Chief Medical Officer
Qin Wei Zhou Chief Operations Officer
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