PharmaMar presents new data on lurbinectedin for Small Cell Lung Cancer at ESMO 2023

The Company will also present other research results on trabectedin for leiomyosarcoma. Madrid, October 18th, 2023. – PharmaMar (MSE:PHM) has announced today that it will present new data on lurbinectedin in Small Cell Lung Cancer (SCLC) at the European Society for Medical Oncology (ESMO) congress, being held in Madrid from October 20-24th. Among the most outstanding studies will be an oral presentation by Dr. Antonio Calles, where final data from the LUPER trial of lurbinectedin in combination with pembrolizumab (immunotherapy) in second-line SCLC will be presented. The presentation called “Lurbinectedin (LUR) in combination with pembrolizumab (PBL) in relapsed small cell lung cancer (SCLC): the phase 1/2 LUPER study” concludes that the combination of lurbinectedin and pembrolizumab is an effective second-line treatment for SCLC in patients who did not receive prior immunotherapy, achieving in some cases deep and durable responses, with a manageable safety profile and no new emerging signs of toxicity when combining the two drugs. Dr. Antonio Calles, Specialist in Medical Oncology at the Hospital General Universitario Gregorio Marañón, Madrid, Spain, who has led the study, comments “the combination represents an opportunity for those patients with metastatic SCLC, who could not be treated with first-line immunotherapy. The treatment achieved a confirmed response rate of 46.4%, including deep and durable responses that exceeded one year in some patients. Median Progression-Free Survival (PFS) was significantly longer for platinum-sensitive patients compared to platinum-resistant patients, with a PFS of 10 versus3 months, respectively. Currently, the only treatment other than lurbinectedin approved for this indication in the last 2 decades, has a response rate of only ~20% and a PFS of 4 months, in addition to very significant toxicity. However, here we saw no unexpected side effects both drugs could be safely combined at full doses”. Dr. Ali Zeaiter, Vice President and Head of Clinical Development at PharmaMar said: “We are pleased to present new data on the combination of lurbinectedin with immunotherapy. We believe that these data, with the suggested improvements in patients’ outcomes, confirm once again that lurbinectedin is an important treatment option for relapsed SCLC and support the ongoing investigation of lurbinectedin combination with immunotherapy”. In addition to the above presentation, the study entitled “A randomised, multicenter phase-III study comparing doxorubicin (dox) alone versus dox with trabectedin (trab) followed by trab in non-progressive patients (pts) as first-line therapy, in pts with metastatic or unresectable leiomyosarcoma (LMS): Final results of the LMS-04 study” will show the final Overall Survival (OS) data for the combination of doxorubicin and trabectedin of 33.1 months versus 23.8 months for doxorubicin alone. These data confirm that this is the first drug combination that is able to demonstrate benefit in both PFS and OS in a phase III trial in first-line treatment of metastatic leiomyosarcoma. These data have supported further the rationale of also studying lurbinectedin in sarcoma. Lead investigator, Dr. Patricia Pautier, from the Institut Gustave Roussy in Villejuif, Paris, France, comments “the final results were positive with a median progression-free survival (PFS) statistically improved from 6.2 months with doxorubicin alone to 12.2 months with the combination.” PharmaMar’s abstracts at ESMO 2023 PRODUCTTITLELEAD AUTHORABSTRACT Zepzelca® (lurbinectedin)Lurbinectedin (LUR) in combination with pembrolizumab (PBL) in relapsed small cell lung cancer (SCLC): the phase 1/2 LUPER studyDr. Antonio CallesMini oral presentation   ABSTRACT: 1989MO    DATE: Saturday, October 21st, 14:50 – 14:55 CET   Lurbinectedin (LRB) pharmacokinetics (PK) and safety when co-administered with itraconazole (ITZ) in patients with advanced solid tumorDra. Irene MorenoABSTRACT: 679P   DATE: Monday, October 23rd Supportive measures to control myelosuppression and costs for patients with SCLC with lurbinectedin, CAV or topotecan with or without trilaciclib: a review on the basis of clinical trialsDr. Manuel DomineABSTRACT: 2024P   DATE:  Saturday, October 21st Yondelis® (trabectedin)A randomised, multicenter phase-III study comparing doxorubicin (dox) alone versus dox with trabectedin (trab) followed by trab in non-progressive patients (pts) as first-line therapy, in pts with metastatic or unresectable leiomyosarcoma (LMS): Final results of the LMS-04 study  Patricia PautierProffered Paper presentation   ABSTRACT: #2965   DATE: Sunday, October 22nd, 08:30-10:00 CET TOMAS2: a randomized phase 2 study from the Italian Sarcoma Group (ISG) of trabectedin plus olaparib (T+O) or trabectedin (T) in advanced, metastatic, or unresectable soft tissue sarcomas (STS) after failure of standard treatments.Lorenzo D’AmbrosioProffered Paper presentation   ABSTRACT: #4076   DATE: Sunday, October 22nd, 08:30-10:00 CET.   Tolerability and efficacy of trabectedin plus pegylated liposomal doxorubicin (PLD) in elderly patients with ovarian cancer (OC) – GEICO 105-O StudyMaría Jesús RubioABSTRACT: 770P   DATE: Sunday, October 22nd Trabectedin plus radiotherapy on symptomatic advanced sarcoma patients, results from the SYNERGIAS study: a Spanish group for research in sarcoma (GEIS) phase II studyJavier Martin BrotoABSTRACT: 1926P   DATE: Monday, October 23rd Targeting Microenvironment and Cellular Immunity in Sarcomas with Trabectedin Combined With Metronomic Cyclophosphamide: The TARMIC studyCheng-Ming SuABSTRACT: 1924P   DATE: Monday, October 23rd

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