GSK's Jemperli Achieves Primary Endpoint in Large Global Head-to-Head Phase II Trial for First-Line NSCLC Immunotherapy

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October 19, 2022 /BIOON/ -- GSK recently announced positive topline results from the PERLA Phase 2 clinical trial of Jemperli (dostarlimab), an anti-PD-1 cancer immunotherapy, for the treatment of non-small cell lung cancer (NSCLC). This is a global, randomized, double-blind clinical trial involving 243 patients.Metastatic Non-Squamous Non-Small Cell Lung Cancer (non-squamous NSCLC)Conducted among patients, evaluatedJemperli in combination with chemotherapy, Keytruda (Pembrolizumab, anti-PD-1 therapy, developed by Merck) in combination with chemotherapy, for first-line treatmentEfficacy and safety.

It is worth mentioning that,PERLA is the largest global head-to-head clinical trial of PD-1 inhibitors conducted in the aforementioned patient population.. The results showed,The trial met the primary endpoint of objective response rate (ORR).The full results of the trial, including the primary endpoint of ORR, the key secondary endpoint of progression-free survival (PFS), and the results of the PD-L1 positive subgroup, will be presented at an upcoming scientific conference.

In the PERLA Phase 2 trial, the safety and tolerability of Jemperli were consistent with previous clinical trials of similar regimens. The most common treatment-related adverse reactions were anemia, fatigue, nausea, constipation, cough, dyspnea, vomiting, decreased appetite, and neutropenia.

In addition, GSK has also advanced the 2-arm COSTAR Lung trial into Phase 3. This decision follows the recommendation of the Independent Data Monitoring Committee, given that the trial met the protocol-defined expansion criteria. The Phase 3 COSTAR Lung trial is a randomized, open-label, 3-arm study conducted in patients with advanced NSCLC whose disease has progressed after prior treatment with anti-PD-(L)1 therapy and chemotherapy. The trial aims to evaluate the efficacy and safety of the anti-TIM-3 antibody cobolimab in combination with dostarlimab and docetaxel, as well as dostarlimab in combination with docetaxel, compared to docetaxel alone.

Jemperli is a programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. The drug works by targeting the cellular pathway of PD-1/PD-L1 (proteins present on human immune cells and some cancer cells). Jemperli helps the human immune system fight cancer cells by blocking this pathway.

In the United States, Jemperli has been approved: (1) for the treatment of patients whose disease progresses during or after receiving platinum-based chemotherapy,Carrying Defective Mismatch Repair (dMMR), Recurrent or Advanced Endometrial CancerAdult patients; (2) For the treatment of disease progression after prior therapy and no satisfactory alternative options,Carrying dMMR, Recurrent or Advanced Solid TumorsAdult patients. In the EU, Jemperli has been approved: for the treatment of patients with recurrent or advanced endometrial cancer who have progressed during or after platinum-based chemotherapy and carry dMMR/microsatellite instability-high (MSI-H). Notably,Jemperli is the first PD-1 therapy approved for the treatment of endometrial cancer.

Cobolimab is a monoclonal antibody against the inhibitory T-cell receptor TIM-3 (T-cell immunoglobulin and mucin domain protein 3). This drug is a TIM-3 antagonist with potential immune checkpoint inhibition and antitumor activity.

Jemperli and cobolimab were discovered under the collaboration and exclusive license agreement signed between AnaptysBio and TESARO in March 2014. This collaboration has yielded three monospecific antibody drugs that have entered clinical trials, including:PD-1 antagonist dostarlimab (GSK4057190), TIM-3 antagonist cobolimab (GSK4069889), LAG-3 antagonist GSK4074386. In 2019, GSK acquired TESARO for $5.1 billion.GSK is responsible for the ongoing research, development, commercialization, and manufacturing of each product under the agreement. (Bioon.com)

Source: 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