PD-L1 therapies are mainly utilized in patients without genetic drivers. Merck’s KEYTRUDA is generally considered the ‘gold standard’ of care in 1L NSCLC when combined with platinum chemotherapy, regardless of PD-1 status. In comparison to Merck's leading drug KEYTRUDA, GSK's JEMPERLI has revealed a 25% reduced risk of death in patients with newly diagnosed nonsquamous NSCLC, as per recent findings presented on ESMO 2023. 

These results stem from an updated analysis of the Phase II PERLA trial, which marked the world's first global study directly comparing two PD-1 inhibitors. In the primary analysis, JEMPERLI + chemotherapy met its primary endpoint of equivalence, with a favorable numerical trend in overall response rate (ORR) and progression-free survival compared to KEYTRUDA + chemotherapy.

At data cut-off on 07 July 2023, 121 and 122 patients in the JEMPERLI + chemotherapy and KEYTRUDA + chemotherapy arms respectively, were randomized and treated. OS maturity was 55%. Median OS was 19.4 months in the JEMPERLI + chemotherapy arm vs. 15.9 months (95% CI 11.6, 19.3) in the KEYTRUDA + chemotherapy arm, after median follow-up (IQR) of 20.7 (17.3, 24.0) and 21.6 (18.3, 24.1) months respectively, with a similar trend across PD-L1 subgroups. 

GSK has initiated a Phase III clinical trial in which JEMPERLI and the chemotherapy drug docetaxel are being tested together, either with or without their experimental TIM-3 inhibitor Cobolimab. This trial is designed for NSCLC patients who have experienced disease progression after receiving first-line treatment consisting of a combination of a PD-1/L1 inhibitor and chemotherapy.

KOL insights

“PERLA OS. Is Dostsr superior to Pembro? This head 2 head large phase 2 trial. ORR benefit maintained. V encouraging OS trend HR=0.75. Interesting strong signal. Looking forward to further development.”- Thoracic Oncologist, UK

Conclusion

While JEMPERLI showed favorable outcomes in direct comparisons with KEYTRUDA in NSCLC, it appears that JEMPERLI'S performance was less effective than KEYTRUDA in their respective trials when it came to preventing disease progression in patients with primary advanced or first recurrent endometrial cancer. The results do endorse the investigation of JEMPERLI within new treatment combinations. It was noted that the ongoing Phase II GALAXIES LUNG-201 study is actively enrolling participants. This study aims to evaluate the safety, effectiveness, pharmacokinetics, and pharmacodynamics of novel immune-oncology (IO) combinations versus single-agent IO treatments in patients with high PD-L1 levels who have not received prior treatment and have unresectable, locally advanced, or metastatic NSCLC. PD-L1 therapies are mainly utilized in patients without genetic drivers. Merck’s KEYTRUDA is generally considered the ‘gold standard’ of care in 1L NSCLC when combined with platinum chemotherapy, regardless of PD-1 status. DelveInsight estimates that the total PD-L1 in NSCLC market size in the 7MM is expected to reach nearly USD 20 million by 2032. Several anti-PD-1/L1 therapies are expected to enter the NSCLC market, but given how well versed physicians are with the current drugs, a major market disruption from new anti-PD-1/L1 therapies entrants in this segment is not anticipated. 

For more insight into the patient's burden/epidemiology, treatment, and changing market landscape-related advancements, refer to the Programmed death-ligand 1 (PD-L1) Non-small Cell Lung Cancer (NSCLC) Market Report

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.