On April 25, 2024 PharmaMar (MSE:PHM) reported that it will present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), that will take place between the 31st of May and the 4th of June in Chicago, U.S.A., the results of the Phase II PM1183-A-014-15 single-arm basket study, which evaluates lurbinectedin in combination with irinotecan in patients with relapsed Small Cell Lung Cancer (SCLC) after one prior platinum-containing line of treatment (Press release, PharmaMar, APR 25, 2024, View Source [SID1234642349]). The results showed a clear synergy on combining these two compounds that strengthens the use of lurbinectedin.

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PM1183-A-014-15 is a multicenter, open-label Phase I/II Basket study of lurbinectedin in combination with irinotecan in relapsed first lines patients. The study enrolled 101 patients in the SCLC cohort, and the results showed a good outcome in this patient population, included in one arm of the lurbinectedin plus irinotecan combination of the LAGOON study. These results refer to the Overall Response Rate (ORR), Duration of Response (DoR), Progression-Free and Overall Survival (PFS and OS), along with a manageable safety and tolerability profile.

Dr. Luis Paz-Ares Rodríguez, Head of Medical Oncology at the "Hospital Universitario 12 de Octubre" commented: "although both irinotecan and lurbinectedin have demonstrated activity separately in monotherapy in SCLC, these compounds with different mechanisms of action have shown an important synergy when combined".

Luis Mora, Managing Director of the Oncology Business Unit said: "These results are of special importance, given that the same regimen used in this study is being evaluated in the LAGOON Phase III study. The results observed in the relapsed SCLC cohort reinforce the rationale of one of the experimental arms of the LAGOON trial currently in progress".

As SCLC is a tumor addicted to transcription, the combination of an active transcription inhibitor (lurbinectedin) that blocks its promoter region with a topoisomerase I inhibitor (irinotecan) that is necessary to prevent DNA torsional stress during the transcription makes sense scientifically. It has been published in preclinical assays that there is a strong synergy combining lurbinectedin with irinotecan. Now, the synergy observed by combining these two drugs with different mechanisms of action inhibiting the transcription, is also shown in this clinical trial, which makes it very interesting and promising that one of the arms of the LAGOON trial consists of this combination.

The full list of PharmaMar or partner-supported presentations at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting are:

PRODUCT TITLE LEAD AUTHOR ABSTRACT
Zepzelca (lurbinectedin) Efficacy and safety of lurbinectedin (LUR) with irinotecan (IRI) in patients (Pts) with relapsed small cell lung cancer (SCLC): Results from a phase 2 expansion cohort. Luis G. Paz-Ares PhD ABSTRACT: 8094 TYPE: Poster Session SESSION: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers POSTER: 356 DATE: June 6th, 2024 (01:30 PM- 04:30 PM CDT)
Efficacy and safety of lurbinectedin (LUR) with irinotecan (IRI) in a phase 2 expansion cohort of patients (Pts) with synovial sarcoma (SS). Gregory Michael Cote MD, PhD ABSTRACT: 11560 TYPE: Poster Session SESSION: Sarcoma POSTER: 486 DATE: June 1st, 2024 (01:30 PM- 04:30 PM CDT)
Randomized controlled, open-label, phase IIb/III study of lurbinectedin in combination with doxorubicin versus doxorubicin alone as first-line treatment in patients with metastatic leiomyosarcoma. Gregory Michael Cote MD, PhD ABSTRACT: TPS11590 TYPE: Poster Session SESSION: Sarcoma POSTER: 514a DATE: June 1st, 2024 (01:30 PM- 04:30 PM CDT)
A phase II study of lurbinectedin with or without avelumab in small cell carcinoma of the bladder (LASER). Nicholas I. Simon MD, MSc ABSTRACT: TPS4629 TYPE: Poster Session SESSION: Genitourinary Cancer—Kidney and Bladder POSTER: 313a DATE: TBD