With Dostarlimab's "head-to-head" K drug, GSK announced that the PERLA study reached the primary endpoint of ORR

On 5 October, GSK announced that its PD-1 monoclonal antibody Jemperli (dostarlimab) combined with chemotherapy head-to-head comparison of Keytruda plus chemotherapy first-line therapy for metastatic non-squamous non-small cell lung cancer (NSCLC) Phase II PERLA trial achieved positive results, reaching the objective response rate (ORR) primary endpoint
.

PERLA, a global, randomized, double-blind, Phase II trial of 243 patients, is the world's largest head-to-head PD-1 inhibitor trial to assess the efficacy and safety
of dostarlimab combination chemotherapy versus K combination chemotherapy first-line treatment in patients with metastatic non-squamous NSCLC.
The primary endpoint was the objective mitigation rate (ORR)
assessed by the Independent Review Committee on Blazing in accordance with RECIST v1.
1.
Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety
.
GSK said the results of the specific study will be announced
at the upcoming meeting.

The safety and tolerability of dostarlimab in this trial was consistent with previous clinical trials
.
The most common adverse effects are anemia, fatigue, nausea, constipation, cough, dyspnea, vomiting, loss of appetite, and neutropenia
.

Dostarlimab is a PD-1 inhibitor originally developed by AnaptysBio, where TESARO acquired the rights to develop and commercialize dostarlimab globally in March 2014 and GSK acquired TESARO in December 2018, bringing dolimstarab into
its pocket.

In April 2021, the FDA accelerated approval of dostarlimab for the treatment of recurrent or advanced endometrial cancer
in adults who have previously undergone platinum-containing chemotherapy and who have DNA mismatch repair defects (dMMR).
In August 2021, the FDA also accelerated the approval of dostarlimab's new indication for the treatment of patients with dMMR relapse or advanced solid tumors who have progressed their disease during or after previous treatment and do not have a satisfactory alternative treatment plan
.

In addition, GSK also announced that it will advance the COSTAR clinical study to Phase III because the trial meets pre-specified extended criteria
.

COSTAR is a global, randomized, open-label phase II/III trial of 750 patients to assess efficacy and safety in patients with cobolimab+dostarlimab+docetaxel vs dostarlimab vs docetaxel monotherapy for advanced non-squamous and squamous NSCLC patients who have progressed after previous anti-PD-(L)1 combination chemotherapy, with the primary endpoint being OS
.

Cobolimab is a TIM-3 monoclonal antibody, one of the hottest immune checkpoints in immunotherapy research after CTLA-4 and PD-1, and is regarded as a "rookie" in anti-cancer targets
.