New drug approved in May | Domestic PARP inhibitors launched, new first-line treatment for HER2-positive gastric cancer

Pamiparib May 7, 2021 Beijing time, the China National Medical Products Administration (NMPA) conditionally approved the PARP inhibitor Pamipa for use in the treatment of at least two lines of chemotherapy in the past, accompanied by germline BRCA (gBRCA) Patients with mutated advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

 The approval is based on the pivotal phase 2 partial clinical results of a phase 1/2 clinical trial (NCT03333915).

A total of 113 patients with high-grade epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) with gBRCA mutations who have received at least two standard chemotherapy in the past were enrolled in the key phase 2 part of the trial in China, including 90 patients with advanced platinum-sensitive ovarian cancer (PSOC) and 23 patients with advanced platinum-resistant ovarian cancer (PROC).

 The effectiveness data of pamidaril is based on 101 patients with evaluable efficacy evaluated by the Independent Review Committee (IRC) according to RECIST v1.
1, including 82 patients with PSOC and 19 patients with PROC.

The median follow-up time for PSOC patients was 17.
0 months, the objective response rate (ORR) was 68.
3% (95% CI: 57.
1, 78.
1), and the median duration of response (DoR) was 13.
8 months (95% CI: 10.
97) , 20.
73); the median follow-up time for PROC patients was 11.
6 months, the ORR was 31.
6% (95%CI: 12.
6, 56.
6), and the median DoR was 11.
1 months (95%CI: 4.
21, 16.
59).

Pamiparib is generally tolerated and has the same safety in the PSOC and PROC cohorts, similar to other PARP inhibitors.

Pembrolizumab May 5, 2021 Eastern Time, the U.
S.
Food and Drug Administration (FDA) accelerated the approval of pembrolizumab in combination with trastuzumab and fluoropyrimidine/platinum-based chemotherapy, first-line Treatment of HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

This approval is based on the interim analysis results of the ongoing KEYNOTE-811 (NCT03615326) study for the first 264 patients.

KEYNOTE-811 is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study, enrolling patients with HER2 positive (center confirmed IHC 3+ or IHC 2+/ISH>2.
0) advanced gastric or gastroesophageal junction adenocarcinoma , Has not previously received systemic treatment for metastatic disease.

The results showed that the ORR of the pembrolizumab group was 74% [complete response (CR) rate 11%, partial response (PR) rate 63%], and the ORR of the placebo group was 52% (CR rate 3.
1%, PR rate 49 %) (One-sided P value<0.
0001).

The median DoR of the pembrolizumab group was 10.
6 months, while that of the placebo group was 9.
5 months.

 In terms of safety, the adverse reactions of patients treated with pembrolizumab are consistent with the known safety of the drug.

 References: [1] China National Medical Products Administration (NMPA) official website.
Retrieved May 07, 2021, from [2] FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer.
News release.
FDA.
May 5, 2021.
Accessed May 5, 2021.
https://bit.
ly/3b027iL