Amongst sufferers with small cell lung most cancers (SCLC), therapy with Imdelltra (tarlatamab-dlle) was discovered to enhance general survival (OS) in comparison with chemotherapy, no matter chemotherapy-free interviews (CFIs) or prior administration of anti-PD-(L)1 remedy, trial outcomes have proven.
Knowledge from the section 3 DeLLphi-304 trial have been introduced on the European Society for Medical Oncology 2025 Congress in Berlin.
The median OS was 10.9 months within the Imdelltra arm versus 6.4 months within the chemotherapy arm amongst sufferers with a CFI of lower than 90 days. The 12-month OS charges on this inhabitants have been 40% versuus 24% with Imdelltra and chemotherapy, respectively.
Amongst sufferers with a CFI of 90 days or longer, the median OS was 17.1 months in contrast with 10.6 months in every arm, with respective 12-month OS charges of 64% and 48. Concerning sufferers with illness development inside two weeks of their most up-to-date platinum-containing therapy, the Kaplan-Meier estimated six-month OS charges have been 55% with Imdelltra and 35% with chemotherapy.
Amongst sufferers with prior receipt of anti–PD-(L)1 brokers, the median OS was 14.1 months within the Imdelltra arm and eight.3 months within the chemotherapy arm; the respective 12-month OS charges have been 53% versus 36%. Within the group of sufferers with out prior anti–PD-(L)1 remedy, the median OS was 13.6 months versus 8.3 months, and the 12-month OS charges have been 53% versus 40%. Total, information confirmed that prior publicity to anti–PD-(L)1 brokers didn’t have an effect on OS advantages with Imdelltra vs chemotherapy.
“Within the second line, customary chemotherapies have demonstrated modest survival advantages, particularly [in] these sufferers with platinum-resistant illness, [who] typically have a poor prognosis. DeLLphi-304 is the primary randomized section 3 trial to reveal superior OS with [Imdelltra] in contrast with customary chemotherapy. Importantly, this survival profit prolonged to sufferers with platinum-resistant illness,” presenting creator Dr. Pedro F. Simoes da Rocha, of Vall d’Hebron College Hospital and Vall d’Hebron Institute of Oncology in Barcelona, Spain, said within the presentation. “These findings reinforce using [Imdelltra] as a typical of care in second-line SCLC, together with these sufferers with worse prognosis, akin to [those] with platinum-resistant illness.”
Within the randomized DeLLphi-304 trial, 509 sufferers have been assigned to obtain Imdelltra (254 sufferers) or investigator’s alternative of chemotherapy (255 sufferers), which included choices of topotecan (185 sufferers), lurbinectedin (47 sufferers) and amrubicin (23 sufferers). Investigators stratified sufferers by prior receipt of anti–PD-(L)1 brokers, CFI interval, presence of mind metastases and meant chemotherapy.
Within the Imdelltra and chemotherapy arms, respectively, 43% and 45% of sufferers had a CFI of lower than 90 days, and 57% and 55% had a CFI of 90 days or longer. Moreover, 71% of sufferers in each arms had prior receipt of anti–PD-(L)1 remedy, whereas 29% from each arms didn’t. Investigators famous that subgroup baseline traits seemed to be balanced between therapy arms.
Throughout the completely different CFI and anti–PD-(L)1 subgroups, charges of grade 3 (extreme) or larger treatment-related negative effects ranged from 24% to 30% within the Imdelltra arm and 58% to 69% within the chemotherapy arm. Any-grade occasions of cytokine launch syndrome (CRS) occurred in 51% to 59% of sufferers who obtained Imdelltra throughout numerous subgroups, and subgroup standing didn’t influence the chance of CRS.
The FDA granted accelerated approval toImdelltra as a therapy for sufferers with extensive-stage SCLC following development on prior platinum-based chemotherapy in Could 2024. Supporting information for this indication got here from the section 2 DELLphi-301 trial.
References
- “Tarlatamab as second-line (2L) therapy for small cell lung most cancers (SCLC): Outcomes by chemotherapy-free interval (CFI) and prior PD-(L)1 inhibitor use within the section 3 DeLLphi-304 trial” by Dr. Pedro F. Simoes da Rocha et al., introduced on the European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. LBA101.
- “FDA grants accelerated approval to tarlatamab-dlle for intensive stage small cell lung most cancers,” information launch. https://tinyurl.com/48k34rw5
