Lilly and Innovent’s Sintilimab: ESMO 2021

Sintilimab Drug

With ESMO 2021 annual meeting around the corner, pharma giants, namely Roche, Daiichi Sankyo, Mirati Therapeutics, Merck, BMS, Innovent Biologics, Coherus BioSciences, Bayer, and others are eagle eyeing this opportunity to present their data readouts from different oncology indications, including GI cancers.

ORIENT-16 trial: Evaluating sintilimab along with chemotherapy as 1L therapy for patients with Unresectable or metastatic gastric or gastroesophageal adenocarcinoma

Sintilimab is a PD-1 inhibitor developed by Innovent and Eli Lilly. It is approved in China with the brand name Tyvyt to treat patients with Hodgkin lymphoma, non-small-cell lung cancer (NSCLC), or hepatocellular carcinoma. Additionally, in May 2021, the US FDA accepted for review the BLA for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of NSCLC. Currently, the drug is being investigated exclusively in China in a Phase III trial in combination with the chemotherapy agents in patients with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma. The drug demonstrated improvement in overall survival compared with chemotherapy alone, reaching the predefined primary endpoint of the Phase II ORIENT-16 trial. It also demonstrated a consistent safety profile. Followed by the positive Phase II results, the company is set to present the first data from the ORIENT-16 Phase III trial (Abstract LBA53) at the ESMO 2021. Based on the already published positive Phase II results and the much-awaited Phase III results, we remain optimistic about the drug’s entry into the market.


ORIENT-15 trial: Frontline sintilimab along with chemotherapy improves Overall Survival (OS) in esophageal squamous cell carcinoma

Apart from sintilimab along with chemotherapy for patients with gastric or gastroesophageal adenocarcinoma, the company is quite excited about the promising safety, efficacy results from another Phase III trial of sintilimab, which is being investigated in combination with chemotherapy as a first-line treatment for patients with unresectable or metastatic gastric or gastroesophageal adenocarcinoma. It has been reported that the median OS among the patient population is only 10 months, thereby representing an unmet medical need. Previous research around the combination of nivolumab (Opdivo) and pembrolizumab (Keytruda) compared with chemotherapy showed that OS could be improved upon in the second-line setting, suggesting a possibility to bring the strategy into the frontline setting. Innovent believes that the encouraging results previously reported for the ORIENT-15 trial, with a satisfactory safety profile, uphold the therapy’s favorable benefit–risk profile as an important new treatment option for esophageal squamous cell cancer patients. The trial’s primary endpoints included OS in all randomized patients and OS in the PD-L1–positive population. Secondary endpoints include objective response rate, progression-free survival, disease control rate, and duration of response. Moreover, the trial is conducted in China only. The company is prepared to present the data from the ORIENT-15 Phase III trial (Abstract LBA52) at the ESMO 2021.

Expert opinion: “We are encouraged by these interim results of the ORIENT-15 study, which demonstrated that sintilimab in combination with chemotherapy prolonged overall survival in the first-line treatment of patients with ESCC, regardless of PD-L1 status.”

–       Oncologist, the United Family New Hope Oncology Center at Peking University Cancer Hospital, and the principal investigator of ORIENT-15


Apart from much-awaited and exciting results from Innovent Biosciences, we cannot overlook the assets under clinical development by Roche, Daiichi Sankyo, Mirati Therapeutics, Merck, BMS, Coherus BioSciences, Leap Therapeutics, BeiGene, MacroGenics, Zymeworks, and Bayer for GI cancers. Indeed, the clinical development pipeline for GI cancers is well stocked with drugs that might pertain to new approvals following ESMO 2021.