Express In the treatment of non-small cell lung cancer, GSK has made excellent clinical progress in the development of PD-1 antibodies and TIM-3 inhibitors

Today GSK announced that its combination therapy of PD-1 antibody Jemperli (dostarlimab) and chemotherapy has obtained positive top-line results
in the PERLA trial.
According to the press release, Jemperli reached the primary endpoint
of the trial in the largest head-to-head PD-1 inhibitor trial to date in the metastatic non-small cell lung cancer (NSCLC) patient population.
In addition, GSK's emerging immune checkpoint inhibitor cobolimab and Jemperli combination therapy trial is also about to enter the phase 3 clinical trial phase
for the treatment of patients with advanced NSCLC.

Lung cancer is the leading cause of cancer death in both men and women, accounting for about one-fifth
of all cancer deaths.
The number of lung cancer patients in China accounts for more than
one-third of the total number of lung cancer patients in the world.
Lung cancers are commonly classified as NSCLC and small cell lung cancer (SCLC), of which 80-85% are non-small cell lung cancers
.
Most patients with non-small cell lung cancer are advanced at the time of
diagnosis.

Jemperli is a kind of PD-1 immune checkpoint inhibitor, which can avoid the interaction between PD-1 receptors and PD-L1 and PD-L2 ligands by binding to PD-1 receptors, thereby blocking their mediated immunosuppressive response, enabling T cells to proliferate, cytokine production, and then help the body's immune system restore anti-tumor ability
.
Last year, Jemperli was accelerated by the US FDA for the treatment of patients with recurrent or advanced endometrial cancer, as well as patients with recurrent or advanced solid tumors with mismatch repair defects (dMMR
).
Cobolimab is a monoclonal antibody targeting T cell immunoglobulin and mucin and 3 (TIM-3), which has the potential to become an immune checkpoint inhibitor and has anti-tumor activity
.

Image source: 123RF

PERLA is a global, randomized, double-blind Phase 2 clinical trial comparing the efficacy and safety
of Jemperli/chemotherapy combination therapy with PD-1 antibody Keytruda (pembrolizumab)/chemotherapy as first-line therapy in patients with metastatic NSCLC.
A total of 243 patients enrolled in these metastatic NSCLC patients had tumors that could be targeted by approved targeted therapies
.
The primary endpoint of the trial was objective response rates reviewed by blind independent centers according to the RECIST v1.
1 criteria, and the secondary endpoints were progression-free survival, total survival, and safety
assessed by researchers against the RECIST v1.
1 criteria.
This trial was not designed to assess the efficacy of combination therapy, and data to date show that Jemperli achieved the primary endpoint
of objective response rates.

COSTAR Lung is a global, randomized, open-label clinical phase 2/3 trial to test the efficacy and safety of cobolimab/Jemperli/docetaxel, Jemperli/docetaxel, and docetaxel monotherapy, with a total of 750 patients with advanced NSCLC who had previously received anti-PD-(L)1 and platinum drugs and developed disease progression
.
Enrolled patients do not have tumors with genetic mutations
that can be targeted by approved targeted therapies.
The primary endpoint of the trial was overall survival
.
According to the evaluation of the Independent Data Monitoring Committee, the data show that according to the trial protocol, the trial meets the predetermined criteria for extended studies and is recommended for admission to Phase 3 clinical studies
.

Dr Hesham Abdullah, Global Head of Cancer R&D and Senior Vice President, GSK, said: "These trial data support Jemperli as the backbone of our ongoing immuno-cancer research, as well as a single-agent or in combination with standard treatments as a development project for modern cancer therapies for the benefit of patients who
currently have only limited treatment options.
”

Resources:

[1] GSK announces positive headline results from PERLA, the phase II trial of Jemperli (dostarlimab) plus chemotherapy in patients with metastatic non-squamous non-small cell lung cancer.
Retrieved October 5, 2022 from WuXi AppTec content team focuses on global biomedical health research advances
.
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