KEY TAKEAWAYS
- The phase II trial aimed to determine whether PARPi plus pembrolizumab maintenance therapy improves PFS in stage IV NSCLC patients who have progressed after SOC treatment.
- The therapy showed promising efficacy and manageable safety in stage IV non-squamous NSCLC, justifying further evaluation in larger trials.
Carboplatin, pemetrexed, and pembrolizumab (CPP), followed by pemetrexed and pembrolizumab (PP), is the standard treatment for non-squamous metastatic non-small cell lung cancer(NSCLC), and PARP inhibitors(PARPi) may be an effective treatment option for patients with BRCAness.
Researchers aimed to determine whether PARPi plus pembrolizumab maintenance therapy improves progression-free survival(PFS) in stage IV NSCLC patients who have progressed after standard of care(SOC) treatment.
The study included NSCLC patients eligible for CPP. Those who did not progress after 4 CPP cycles received maintenance with rucaparib (600 mg PO BID) and pembrolizumab (200 mg IV every 21 days). The primary objective was evaluating efficacy through PFS, while secondary objectives included OS, safety, and ORR assessment.
Of the 25 enrolled patients, 11 did not proceed with maintenance, citing reasons such as CPP progression (3/11), physician discretion (2/11), adverse events(AE) from CPP (2/11), study termination (2/11), patient passing away unrelated to the study (1/11), and incorrect enrollment (1/11). The study focussed on the early results from the 14 patients who received at least one maintenance cycle with rucaparib and pembrolizumab. The median age was 59, 64% were female, all had adenocarcinoma histology, and one had stable treated brain metastases.
The study closed early due to Clovis’ financial insolvency. Median PFS from enrollment was 11.4 months, median OS was 37.6 months, and ORR from enrollment was 64% (9/14; 8 PR, 1 CR), 95% CI (0.35-0.87). No serious adverse events(SAEs) were reported, and the highest grade of AE was Grade 3, occurring in 50% of patients. The most common treatment-related Grade 3 AE was liver enzyme elevations (28.6%), followed by anemia/leukopenia (14.6%).
PARPi plus pembrolizumab maintenance therapy demonstrated promising efficacy and manageable safety in stage IV non-squamous NSCLC, justifying further evaluation in larger trials.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/2260
Clinical Trial: https://clinicaltrials.gov/study/NCT03559049
Qin A, Morgensztern D, Waqar S, Owen D, Gadgeel S, Schneider B, Kalemkerian G, Rice J, Ramnath N. Phase I/II Study of Rucaparib and Pembrolizumab Maintenance in Stage IV NSCLC after Carboplatin, Pemetrexed, Pembrolizumab.
