Small Cell Lung Cancer (SCLC)

Support for the recommendation is based on phase 3 ADRIATIC trial results showing a 27% reduction in the risk of death with durvalumab vs placebo.

A phase 1a/1b trial showed that ZL-1310 elicited an ORR of 74%, all of which were PRs, in patients with SCLC who received prior chemotherapy.

Sacituzumab govitecan showed promising response and survival data in the extensive-stage small cell lung cancer cohort of the phase 2 TROPiCS-03 trial.

Results from the phase 3 ADRIATIC trial led to the approval of durvalumab in limited-stage SCLC.

Promising phase 1 data appear to support further evaluation of ZL-1310 as a treatment for patients with extensive-stage small cell lung cancer.

Offering certain radiotherapy modalities based on disease burden may play a role in the outcomes of those with ES-SCLC, according to James Ninia, MD.

Developers plan to submit a supplemental NDA for this combination as a first-line maintenance therapy for ES-SCLC in the first half of 2025.

Results showed of the phase 3 ADRIATIC study found that treatment with durvalumab elicited similar radiation pneumonitis incidences vs placebo for LS-SCLC.

Data show that twice-daily radiotherapy may confer improved survival vs once-daily radiation in patients with limited-stage small cell lung cancer.

BMS-986012 in combination with nivolumab/chemotherapy showed numerical PFS improvements in those with and without brain metastases at baseline.

The magnitude of benefit with durvalumab was particularly consistent within prophylactic cranial irradiation and radiation subgroups in the ADRIATIC trial.

Supporting data for the designation comes from the ARTEMIS-001 trial evaluating preliminary safety and antitumor activity of GSK’227 in solid tumors.

Data from the phase 3 ADRIATIC trial support the supplemental biologics license application for durvalumab in this limited-stage SCLC population.

The overall survival data in the phase 3 KeyVibe-008 trial met the prespecified futility criteria.

The phase 2 DELLphi-301 trial showed durable response rates when tarlatamab was used to treat extensive-stage small cell lung cancer.

Treatment with SNB-101 previously demonstrated tolerability among patients with solid tumors in a phase 1 trial.

Treatment with durvalumab raises no new safety signals among patients with limited-stage small cell lung cancer in the phase 3 ADRIATIC trial.

A post hoc analysis of lurbinectedin showed an improvement in the overall response rate compared with topotecan for patients with small cell lung cancer.

The FDA sets a Prescription Drug User Fee Act date of June 12, 2024, for tarlatamab as a therapy for patients with advanced small cell lung cancer.

Investigators are assessing BI 764532 in extensive-stage small cell lung cancer and other neuroendocrine carcinoma as part of the phase 2 DAREON-5 study.

Findings from the phase 3 SKYSCRAPER-02 trial support outcomes following atezolizumab plus chemotherapy for patients with extensive-stage small cell lung cancer.

Patients with extensive-stage small cell lung cancer who receive trilaciclib appear to experience lower rates of hematologic adverse effects than those who are not treated with the agent.

The phase 2 TROPiCS-03 trial helped elicit responses and disease control in patients with extensive-stage small cell lung cancer who received second-line sacituzumab govitecan.

Tarlatamab may represent a new immunotherapeutic approach for patients with small cell lung cancer, according to the investigators of the phase 2 DeLLphi-301 trial.

Developers plan to assess onvansertib plus standard of care as a frontline treatment for patients with metastatic pancreatic ductal adenocarcinoma in an investigator-initiated trial.

Data from a phase 1 trial highlight a clinically acceptable safety profile for BI 764532 in patients with extensive-stage small cell lung cancer and extrapulmonary neuroendocrine carcinomas.

Alisertib will be assessed in patients with small cell lung cancer as part of the phase 2 Study PUMA-ALI-4201.

Treatment with BI 764532 produces a manageable safety profile among those with small cell lung cancer and neuroendocrine carcinoma in a phase 1 trial.

Benmelstobart plus anlotinib and chemotherapy produce survival benefits in extensive-stage small cell lung cancer across all patient subgroups in the phase 3 ETER701 trial.

Investigators of the phase 1/2 Acclaim-3 trial will assess quaratusugene ozeplasmid in combination with atezolizumab as a treatment for those with extensive-stage small cell lung cancer.