Selective Personalized RadioImmunotherapy for Locally Advanced Non鈥揝mall-Cell Lung Cancer Trial (SPRINT)

鈥� An ASCO Reading Room selection

March 8, 2024

Nitin Ohri, MD, MS, Shruti Jolly, MD, Benjamin T. Cooper, MD, Rafi Kabarriti, MD, William R. Bodner, MD, Jonathan Klein, MD, Chandan Guha, MD, PhD, Shankar Viswanathan, PhD, Elaine Shum, MD, Joshua K. Sabari, MD, Haiying Cheng, MD, PhD, Rasim A. Gucalp, MD, Enrico Castellucci, MD, Angel Qin, MD, Shirish M. Gadgeel, MD, and Balazs Halmos, MD

Journal of Clinical Oncology

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Below is the abstract of the article.

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Purpose

Standard therapy for locally advanced non–small-cell lung cancer (LA-NSCLC) is concurrent chemoradiotherapy followed by adjuvant durvalumab. For biomarker-selected patients with LA-NSCLC, we hypothesized that sequential pembrolizumab and risk-adapted radiotherapy, without chemotherapy, would be well-tolerated and effective.

Methods

Patients with stage III NSCLC or unresectable stage II NSCLC and an Eastern Cooperative Oncology Group performance status of 0-1 were eligible for this trial. Patients with a PD-L1 tumor proportion score (TPS) of ≥50% received three cycles of induction pembrolizumab (200 mg, once every 21 days), followed by a 20-fraction course of risk-adapted thoracic radiotherapy (55 Gy delivered to tumors or lymph nodes with metabolic volume exceeding 20 cc, 48 Gy delivered to smaller lesions), followed by consolidation pembrolizumab to complete a 1-year treatment course. The primary study end point was 1-year progression-free survival (PFS). Secondary end points included response rates after induction pembrolizumab, overall survival (OS), and adverse events.

Results

Twenty-five patients with a PD-L1 TPS of ≥50% were enrolled. The median age was 71, most patients (88%) had stage IIIA or IIIB disease, and the median PD-L1 TPS was 75%. Two patients developed disease progression during induction pembrolizumab, and two patients discontinued pembrolizumab after one infusion because of immune-related adverse events. Using RECIST criteria, 12 patients (48%) exhibited a partial or complete response after induction pembrolizumab. Twenty-four patients (96%) received definitive thoracic radiotherapy. The 1-year PFS rate is 76%, satisfying our efficacy objective. One- and 2-year OS rates are 92% and 76%, respectively. The most common grade 3 adverse events were colitis (n = 2, 8%) and esophagitis (n = 2, 8%), and no higher-grade treatment-related adverse events have occurred.

Conclusion

Pembrolizumab and risk-adapted radiotherapy, without chemotherapy, are a promising treatment approach for patients with LA-NSCLC with a PD-L1 TPS of ≥50%.

Read an interview about the study here.

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Selective Personalized RadioImmunotherapy for Locally Advanced Non鈥揝mall-Cell Lung Cancer Trial (SPRINT)

Primary Source

Journal of Clinical Oncology

Source Reference:

番茄社区