JASPER: Phase 2 trial of first‐line niraparib plus pembrolizumab in patients with advanced non–small cell lung cancer
Open accessAbstract
Background: Poly(ADP‐ribose) polymerase (PARP) inhibitors may synergize with programmed cell death receptor‐1 (PD‐1) inhibitors to enhance adaptive and innate antitumor immune responses. In the phase 2 JASPER study (NCT03308942), the PARP inhibitor niraparib was evaluated in combination with the PD‐1 inhibitor pembrolizumab in patients with metastatic and/or locally advanced non–small cell lung cancer (NSCLC). Methods: Patients whose tumors had programmed cell death ligand 1 (PD‐L1) tumor proportion scores (TPS) ≥50% (cohort 1) or 1%‐49% (cohort 2) received first‐line niraparib (200 mg once daily) plus pembrolizumab (200 mg every 3 weeks). The primary end point was investigator‐assessed objective response rate (ORR). Secondary end points included duration of response (DoR), progression‐free survival (PFS), overall survival (OS), safety, and pharmacokinetics. Results: Thirty‐eight patients were enrolled in cohorts 1 and 2. In cohort 1, ORR (95% confidence interval [CI]) was 56.3% (9 of 16 patients; 29.9%‐80.2%); 2 of 16 patients had complete responses and 7 of 16 had partial responses (PRs). In cohort 2, ORR was 20.0% (5.7%‐43.7%) with 4 of 20 PRs. In cohorts 1 and 2, the median DoR was 19.7 months (95% CI, 4.2 months to not estimable [NE]) and 9.4 months (95% CI, 4.2 months to NE), the median PFS was 8.4 months (95% CI, 3.9‐22.1 months) and 4.2 months (95% CI, 2.0‐6.2 months), and the median OS was NE (95% CI, 6.0 months to NE) and 7.7 months (95% CI, 4.0‐12.5 months), respectively. Grade ≥3 treatment‐emergent adverse events occurred in 88.2% and 85.7% of patients in cohorts 1 and 2, respectively. Safety was consistent with known profiles of single‐agent niraparib and pembrolizumab. Conclusions: Niraparib plus pembrolizumab showed clinical activity in patients with advanced and/or metastatic NSCLC. Lay Summary: The JASPER clinical trial studied a new combination treatment for advanced or metastatic non–small cell lung cancer (NSCLC). Pembrolizumab, a drug approved for NSCLC, was given with niraparib. Previous research showed that these 2 drugs together might work better than either drug alone. This study found that more than half of patients with high levels of a tumor marker responded to the combination, and one‐fifth of patients with lower levels of the marker responded. The types of side effects from the combination were similar to side effects from both drugs alone. These results support more research on this combination.
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In the phase 2 study JASPER, niraparib plus pembrolizumab exhibited powerful antitumor activity especially in PD-L1high advanced NSCLC patients (ORR 56.3%).
“Additionally, in the phase 2 study JASPER, niraparib plus pembrolizumab exhibited a powerful antitumor activity especially in PD-L1high (tumor proportion scores TPS ≥ 50%) advanced NSCLC patients (ORR: 56.3%) [227].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [227]
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- Authors
- Ramalingam, S. S., Thara, E., Awad, M. M., Dowlati, A., Haque, B., Stinchcombe, T. E., Dy, G. K., Spigel, D. R., Lu, S., Iyer Singh, N., Tang, Y., Teslenko, I., & Iannotti, N.
- Affiliations
- Winship Cancer Institute (US)
- Oncology Institute of Hope and Innovation (US)
- Dana-Farber Cancer Institute (US)
- University Hospitals Seidman Cancer Center (US)
- Kadlec Clinic (US)
- Duke University (US)
- Roswell Park Comprehensive Cancer Center (US)
- Sarah Cannon (US)
- GlaxoSmithKline (United States) (US)
- GlaxoSmithKline Waltham Massachusetts
- Hematology Oncology Associates of the Treasure Coast Port St. Lucie Florida
- Corresponding author
- Ramalingam, Suresh S.
- ORCID
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2021-09-03
- Volume
- 128
- Issue
- 1
- Pages
- 65-74
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- PMC
- PMC9293160
- OpenAlex
- W3196318196
- Cited by
- 75
- References
- 28
- Citations by year
- 2026: 5 · 2025: 19 · 2024: 11 · 2023: 20 · 2022: 18 · 2021: 2
- FWCI
- 4.64
- Type
- journal article
- Language
- en
- Update notices
- erratum (2023-10-13)
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Cancer (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- GlaxoSmithKline (213352)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Keywords
- niraparib, pembrolizumab, non-small cell lung cancer, PARP inhibitors, PD-1 inhibitors, immune checkpoint inhibitor combination, PD-L1 expression, first-line therapy, objective response rate, treatment-emergent adverse events, immunotherapy, metastatic non-small cell lung cancer, locally advanced non-small cell lung cancer, progression-free survival, overall survival, duration of response
- MeSH terms
- Poly(ADP-ribose) Polymerase Inhibitors, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Humans, Indazoles, Lung Neoplasms, Piperidines, Antibodies, Monoclonal, Humanized
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