SPOTLIGHT: Durvalumab shines in real-world trial on NSCLC
Findings from the SPOTLIGHT trial have shown the efficacy of administering durvalumab after chemoradiotherapy (CRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
“To better understand the real-world efficacy of durvalumab after CRT in [this patient setting], we evaluated outcomes in a retrospective, observational cohort study,” said the investigators. “[Our data] are consistent with the results from the phase III PACIFIC trial and indicate that durvalumab is effective in real-world patients.” [N Engl J Med 2017;377:1919-1929; N Engl J Med 2018;379:2342-2350; Ann Oncol 2021;32(Suppl_7):S1417-S1418]
Using data from a US oncology record database, the team evaluated 332 patients (median age 68 years) who were initially diagnosed with stage III NSCLC and received durvalumab. Ninety-three percent received complete concurrent CRT. About 50 percent of participants began durvalumab treatment within the recommended period of 42 days after end of CRT, while 40 percent received durvalumab for ≥11 months. [ELCC 2022, abstract 116P]
Median time to first subsequent therapy (TFST) was not reached. At 1 year, more than two-thirds (70 percent) of participants were alive and had not yet initiated a subsequent therapy. By year 2, the rate dropped to 53 percent.
Similarly, median time to metastasis or death (TTM) was not reached. At the respective 1- and 2-year marks, 67 percent and 56 percent of participants remained alive and free of metastasis.
Although TFST and TTM remain immature owing to the short median follow-up time, the investigators noted that the landmark rates are consistent with those seen in PACIFIC.
Median real-world progression-free survival (PFS) was 17.5 months. “[This] is in alignment with the 16.9-month median PFS in PACIFIC seen after ~5 years’ follow-up,” said the researchers. The fractions of patients who were alive and progression-free at 1 year and 2 years were 58 percent and 45 percent, respectively, which also correlate with that seen in PACIFIC.
Of those who had real-world PFS events (n=166), 54 percent had metastatic progression (with or without nonmetastatic progression), 38 percent had nonmetastatic progression only (as first progression), and 7 percent died without progression. “One patient was considered to have progression as they received subsequent anticancer [therapies], and the reason for durvalumab discontinuation was not toxic effect,” said the researchers.
The most common sites of metastases at first progression were the brain (34 percent), followed by bone (19 percent) and the lungs (16 percent).
Real-world data essential
“Real-world data are critical to understanding whether use of consolidation durvalumab in routine clinical practice demonstrates comparable benefit to that reported in clinical trials and is essential for optimizing management of this patient population,” said the researchers.
“Based on the findings from PACIFIC … durvalumab was approved for patients with stage III NSCLC for whom surgery is not an option, provided they have previously completed treatment with [CRT] without their cancer progressing,” said the researchers, thus establishing consolidation durvalumab as standard of care for this patient cohort.
“Together with previously reported safety data, [our findings imply] that durvalumab after CRT is effective and well tolerated in patients with unresectable stage III NSCLC, suggesting that the treatment benefit observed in PACIFIC can be translated to everyday clinical practice in the US,” they concluded.