Durvalumab Plus Platinum-Etoposide Displays Feasibility in ES-SCLC

Fact checked by" Russ Conroy
Justin Mancini
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Grade 3 immune-mediated AEs were observed in 11 patients with extensive-stage small cell lung cancer, which included 2 instances of pneumonitis.

After a median follow-up of 9.4 months, the median PFS was 6.1 months, and the 12-month rate was 21.0%.

After a median follow-up of 9.4 months, the median PFS was 6.1 months and the 12-month rate was 21.0%.

The addition of platinum-etoposide to durvalumab (Imfinzi) as induction therapy plus durvalumab maintenance displayed feasibility in patients with extensive-stage small cell lung cancer (ES-SCLC) with a World Health Organization (WHO)/ECOG performance status of 0 to 2, according to findings from the single-arm phase 3b CANTABRICO trial (NCT04712903) published in Lung Cancer.

Data from the trial revealed that among 101 patients who received at least 1 dose of study medication, any-grade adverse effects (AEs) were observed in 100 (99%). The most common AEs included asthenia (62.4%), anemia (49.5%), neutropenia (35.6%), dyspnea (32.7%), and constipation (26.7%). Additionally, grade 3 or higher AEs were observed in 76.2% of patients, the most common of which included anemia (24.8%), neutropenia (21.8%), thrombocytopenia (8.9%), and asthenia (5.9%).

Furthermore, treatment-related AEs (TRAEs) occurred in 91.1% of patients, the most common of which included asthenia (48.5%), anemia (45.5%), neutropenia (31.7%), and alopecia (23.8%). Moreover, grade 3 or higher TRAEs occurred in 57.4% of patients, and the most common TRAEs included anemia (22.8%), neutropenia (18.8%), and thrombocytopenia (8.9%).

TRAEs leading to treatment discontinuation occurred in 11.9% of patients, 2 patients experienced fatal AEs related to treatment, and serious AEs and TRAEs occurred in 56.4% and 25.7% of patients, respectively. Additionally, immune-mediated AEs (imAEs) occurred in 37.6% of patients, most of which were grade 1 or 2 in severity. In total, 11.9% of patients experienced grade 3 or higher imAEs, with 2 instances of pneumonitis observed in the trial.

“[The results of this] phase 3b trial suggest that first-line treatment of patients with ES-SCLC, with an initial regimen of up to 6 cycles of durvalumab plus platinum-etoposide followed by maintenance durvalumab, is feasible, providing more options in daily clinical practice for the management of these patients depending on their characteristics,” Dolores Isla, of Lozano Blesa University Clinical Hospital in Zaragoza, Spain, and member of the Spanish Society of Medical Oncology, wrote in the publication with study coinvestigators.

Efficacy outcomes from the trial showed that after a median follow-up of 9.4 months (IQR, 6.1-22.5), the median progression-free survival (PFS) was 6.1 months (95% CI, 5.2-6.9) and the 12-month rate was 21.0% (95% CI, 13.0%-29.0%). Moreover, the median overall survival (OS) was 9.6 months (95% CI, 7.8-11.3), with 12- and 24-month rates of 40.7% (95% CI, 31.1%-50.3%) and 25.4% (95% CI, 16.8%-34.0%), respectively.

Additionally, the objective response rate (ORR) was 54.5% (95% CI, 44.7%-64.2%). The median duration of response (DOR) was 5.6 months (95% CI, 4.7-6.5), and the 12-month DOR rate was 35.7% (95% CI, 23.0%-48.4%).

The prospective phase 3b study included patients 18 years or older with histologically or cytologically confirmed ES-SCLC, those who received chemoradiotherapy for limited-stage disease, and those with a treatment-free interval of at least 6 months since prior therapy. All patients received intravenous chemotherapy consisting of 80 to 100 mg/m2 of etoposide on days 1 to 3 of each 21-day cycle plus either carboplatin area under the curve 5 to 6 or 75 to 80 mg/m2 of cisplatin on day 1 of each 3-week cycle.

Intravenous durvalumab was given at 1500 mg every 3 weeks for 4 to 6 cycles with chemotherapy and given alone every 4 weeks as maintenance therapy. Maintenance therapy continued in the absence of clinical or radiological progression per RECIST v1.1 guidelines, intolerable toxicity, withdrawal of consent, or other discontinuation criteria.

The median age in the study was 65 years (IQR, 62-71), with 56.4% of patients being 65 years or older. Most patients were men (67.3%), were White (98.0%), and had formerly smoked (52.5%). A total of 90.1% of patients had ES-SCLC at initial diagnosis, 86.1% had stage IV disease, 63.4% had a WHO performance status score of 1, 10.9% had brain metastases, and 32.7% had liver metastases.

The primary end point of the study was the incidence of grade 3 or higher AEs and imAEs. Secondary end points included median, 6-month, and 12-month PFS; ORR; median and 1-year DOR; and median, 6-month, 12-month, and 18-month OS.

Reference

Isla D, Zugazagoitia J, Arriola E, et al. Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): a single-arm clinical trial. Lung Cancer. 2025;209:108763. doi:10.1016/j.lungcan.2025.108763

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