Hengrui Medicine's 5 anti-tumor studies are selected for Oral link

Article source: Pharmaceutical Guanlan

Recently, the official website of the American Society of Clinical Oncology (ASCO) annual meeting officially announced the abstract of the 2021 ASCO conference.

1.

1.

Mechanism of action: anti-PD-1 monoclonal antibody

Research information: A randomized, double-blind, placebo-controlled Phase 3 clinical study (ESCORT-1st) to evaluate carrelizumab combined with chemotherapy versus chemotherapy for untreated advanced or metastatic esophageal squamous cells Effect for cancer patients

Research information: A randomized, double-blind, placebo-controlled Phase 3 clinical study (ESCORT-1st) to evaluate carrelizumab combined with chemotherapy versus chemotherapy for untreated advanced or metastatic esophageal squamous cells Effect for cancer patients

Research leader: Professor Xu Ruihua, Sun Yat-sen University Cancer Center

Research leader: Professor Xu Ruihua, Sun Yat-sen University Cancer Center

From December 3, 2018 to May 12, 2020, 596 patients received randomization.

In the study, the incidence of ≥ grade 3 treatment-related adverse reactions in the two groups was similar (63.

2.

2.

Mechanism of action: anti-PD-1 monoclonal antibody

Research information: A randomized controlled, double-blind, multi-center phase 3 clinical trial (CAPTAIN-1st) to evaluate the effect of carrelizumab combined with gemcitabine and cisplatin in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma

Research information: A randomized controlled, double-blind, multi-center phase 3 clinical trial (CAPTAIN-1st) to evaluate the effect of carrelizumab combined with gemcitabine and cisplatin in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma

Research leader: Professor Zhang Li, Sun Yat-sen University Cancer Center

Research leader: Professor Zhang Li, Sun Yat-sen University Cancer Center

From November 2018 to November 2019, 263 patients from 28 centers were randomly assigned to carrelizumab + GP (gemcitabine + cisplatin) group (n=134, carrelizumab group) ) Or placebo+GP group (n=129, placebo group).

In terms of side effects, the incidence of ≥3 treatment-related adverse events (TRAEs) was 93% in the carrelizumab group and 90% in the placebo group.

3.

3.

Mechanism of action: CDK4/6 inhibitor

Research information: A multi-center, randomized, phase 3 study (DAWNA-1) to evaluate the effect of dapicilil versus placebo plus fulvestrant in the treatment of HR+/HER2-advanced breast cancer that has relapsed or progressed from previous endocrine therapy

Research information: A multi-center, randomized, phase 3 study (DAWNA-1) to evaluate the effect of dapicilil versus placebo plus fulvestrant in the treatment of HR+/HER2-advanced breast cancer that has relapsed or progressed from previous endocrine therapy

Research leader: Professor Xu Binghe, Cancer Hospital of Chinese Academy of Medical Sciences, National Cancer Center

Research leader: Professor Xu Binghe, Cancer Hospital of Chinese Academy of Medical Sciences, National Cancer Center

361 patients were randomized to receive dapiciride + fulvestrant (n=241, dapiciride group) or placebo + fulvestrant (n=120, placebo group) treatment.

The most common grade 3 or 4 AEs in the dapicillide group were neutropenia (84.

Four, famitinib + carrelizumab

Four, famitinib + carrelizumab

Mechanism of action: multi-target tyrosine kinase inhibitor, anti-PD-1 monoclonal antibody

Mechanism of action: multi-target tyrosine kinase inhibitor, anti-PD-1 monoclonal antibody

Research information: A prospective, one-arm, phase 2 study (FUTURE-C-plus) to evaluate famitinib combined with carrelizumab + albumin paclitaxel in the first-line treatment of immunomodulated advanced triple-negative breast cancer Effect

Research information: A prospective, one-arm, phase 2 study (FUTURE-C-plus) to evaluate famitinib combined with carrelizumab + albumin paclitaxel in the first-line treatment of immunomodulated advanced triple-negative breast cancer Effect

Research leader: Professor Shao Zhimin, Fudan University Affiliated Cancer Hospital

Research leader: Professor Shao Zhimin, Fudan University Affiliated Cancer Hospital

From October 2019 to October 2020, a total of 48 patients were enrolled.

Grade 3 or 4 adverse events were neutropenia, anemia, febrile neutropenia, thrombocytopenia, hypertension, hypothyroidism, proteinuria, sepsis, and immune-related myocarditis.

Five, SHR-1701

Five, SHR-1701

Mechanism of action: PD-L1/TGF-β double antibody

Mechanism of action: PD-L1/TGF-β double antibody

Research information: A phase 1 study exploring the treatment of SHR-1701 in patients with advanced solid tumors

Research information: A phase 1 study exploring the treatment of SHR-1701 in patients with advanced solid tumors

Research leader: Professor Lin Shen, Peking University Cancer Hospital

Research leader: Professor Lin Shen, Peking University Cancer Hospital

Seventeen cases were included in the dose-climbing stage.

PK analysis showed that SHR-1701 has a linear relationship with dose exposure in the dose range of 1-30mg/kg.
Peripheral blood PD-L1 occupancy rate exceeded 90% in all dose groups, and TGF-β1 capture was almost detected in all dose groups.
Of 49 patients, 45 patients completed at least one efficacy evaluation.
The ORR was 17.
8%, and 8 patients achieved partial remission (PR).
The disease control rate (DCR) is 40.
0%.
Most PR patients are still responding (7/8), and the median DoR has not yet been reached.
Based on safety, PK, PD, and efficacy data, the study recommends 30mg/kg Q3W (use once every 3 weeks) as the recommended dose (RP2D) for the Phase 2 study.

Reference materials:

Reference materials:

[1] Hengrui's original research shines on the world stage, and a number of blockbuster studies are shortlisted for the Oral session of the ASCO annual meeting.
Retrieved May 25, 2021, from https://mp.
weixin.
qq.
com/s/p-UTs_D6RtGUt5a4b5V7GQ

[1] Hengrui's original research shines on the world stage, and a number of blockbuster studies are shortlisted for the Oral session of the ASCO annual meeting.
Retrieved May 25, 2021, from https://mp.
weixin.
qq.
com/s/p-UTs_D6RtGUt5a4b5V7GQ

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