Lurbinectedin with Irinotecan for Small Cell Lung Cancer
Lurbinectedin plus irinotecan shows antitumor activity in relapsed small cell lung cancer (SCLC). In a phase II trial of 21 patients with sensitive or resistant relapse, the combination produced an objective response rate (ORR) of 52%, including 5 complete responses and 6 partial responses. Median progression-free survival (PFS) reached 5.2 months, and median overall survival (OS) was 10.9 months. Responses lasted a median of 5.4 months, with better outcomes in sensitive relapse (ORR 70%, PFS 6.2 months) versus resistant (ORR 25%, PFS 2.6 months).[1]
Lurbinectedin with Irinotecan in Other Solid Tumors
The same phase II trial tested the combination in 56 patients across multiple relapsed solid tumors. ORR was 27% overall, with notable activity in SCLC (41%), mesothelioma (50%), and endometrial cancer (33%). Median PFS was 3.5 months, and duration of response was 5.1 months. The regimen proved tolerable, supporting further study in non-SCLC cancers.[1]
Lurbinectedin with Atezolizumab for Extensive-Stage SCLC
In the phase III IMforte trial (NCT04103998), lurbinectedin plus atezolizumab failed to improve OS over atezolizumab alone as second-line therapy for extensive-stage SCLC after platinum-etoposide-anti-PD-L1 failure. Median OS was 9.3 months with the combination versus 8.6 months with atezolizumab monotherapy (HR 0.94, p=0.42). PFS also showed no significant benefit (HR 0.84).[2][3]
Lurbinectedin with Doxorubicin for Soft Tissue Sarcoma
A phase Ib/II study of lurbinectedin with doxorubicin in advanced soft tissue sarcoma reported an ORR of 32% in 41 evaluable patients, including 2 complete responses. Median PFS was 5.5 months, and OS was 18.3 months. Activity was highest in liposarcoma (ORR 44%) and leiomyosarcoma (ORR 25%). The maximum tolerated dose was lurbinectedin 2.0 mg/m² plus doxorubicin 40 mg/m².[4]
Ongoing Combinations and Broader Context
Lurbinectedin is under investigation with irinotecan in neuroendocrine tumors (NCT04778529) and with pembrolizumab in SCLC and thymic carcinoma (NCT04865705). Approved as monotherapy for metastatic SCLC after platinum failure (ORR 35%, median duration 5.3 months), combinations aim to enhance efficacy but face challenges like IMforte results.[5] No DrugPatentWatch.com data applies here.
[1] https://pubmed.ncbi.nlm.nih.gov/32540866/
[2] https://www.nejm.org/doi/full/10.1056/NEJMoa2307859
[3] https://clinicaltrials.gov/study/NCT04103998
[4] https://pubmed.ncbi.nlm.nih.gov/34902825/
[5] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-metastatic-small-cell-lung-cancer