On June 1, 2022 PharmaMar (MSE:PHM) reported that they and their partners will present eight new abstracts from several clinical studies with Zepzelca (lurbinectedin) and Yondelis (trabectedin) during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held June 3-7, 2022 in situ in Chicago, USA and virtually (Press release, PharmaMar, JUN 1, 2022, View Source [SID1234615308]).
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Among the studies to be presented are the poster entitled "Analysis of patients with relapsed small cell lung cancer (SCLC) receiving single-agent lurbinectedin in the phase 3 ATLANTIS trial", which shows the results of a subgroup of 50 patients with SCLC from the phase III ATLANTIS trial who, after having received 10 cycles of lurbinectedin 2.0mg/m2 in combination with doxorubicin, went on to be treated with lurbinectedin as a single agent at the approved dose of 3.2 mg/m2. The results show that these patients tended to maintain or better the tumor response obtained with the combination when switched to lurbinectedin monotherapy, including an increase in the rate of complete responses. These patients also had favorable Overall Survival (OS), with a median of 20.7 months, and no new signs of toxicity were identified.
Under the title "Efficacy and safety of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer: Preliminary results of a phase 1 study", the results of the phase I trial will be presented, in which lurbinectedin monotherapy has shown promising efficacy as a second-line treatment in Chinese patients with SCLC, with acceptable tolerability and a manageable safety profile.
Results from the Phase I trial of lurbinectedin in combination with immunotherapy will also be presented. This poster, entitled "A phase 1/2 trial of lurbinectedin (L) in combination with pembrolizumab (P) in relapsed small cell lung cancer (SCLC): The LUPER study", shows the phase I results of this trial, which demonstrates a manageable safety profile and preliminary antitumor activity of the combination of lurbinectedin with pembrolizaumab in second-line patients with relapsed SCLC, and the trial’s expansion phase is already ongoing.
Finally, with regards to lurbinectedin, data from the cohort of patients with BRCA1/2-associated breast cancer from the Phase II trial with lurbinectedin as a single agent will be presented. The poster "Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study" confirms the activity of lurbinectedin previously observed in this indication.
Studio e la Cura dei Tumori (Italy) will give an oral presentation of the abstract entitled "Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: Results of the expanded cohort of myxoid liposarcoma of the randomized clinical trial from the Italian Sarcoma Group (ISG), the Spanish Sarcoma Group (GEIS), the French Sarcoma Group (FSG), and the Polish Sarcoma Group (PSG)", in which he will present the efficacy results of trabectedin in high-grade myxoid liposarcoma. Thanks to the previous results obtained in this study, the ESMO (Free ESMO Whitepaper) Guidelines included trabectedin as a treatment option for this subtype of sarcoma in 2021.
All ASCO (Free ASCO Whitepaper) poster presentations are available on request to registered participants for 180 days from May 26, 2022: View Source
Highlighted studies at ASCO (Free ASCO Whitepaper) 2022
Zepzelca (lurbinectedin)
TITLE
LEAD AUTHOR ABSTRACT
Analysis of patients with relapsed small cell lung cancer (SCLC) receiving single-agent lurbinectedin in the phase 3 ATLANTIS trial Alejandro Navarro MD ABSTRACT: 207436 POSTER SESION: Lung Cancer—Non-Small Cell Local-Regional/Small
Efficacy and safety of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer: Preliminary results of a phase 1 study Ying Cheng MD ABSTRACT: 207457 POSTER SESSION: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
A phase 1/2 trial of lurbinectedin (L) in combination with pembrolizumab (P) in relapsed small cell lung cancer (SCLC): The LUPER study Antonio Calles MD, MSc ABSTRACT: 210025 POSTER SESSION: Breast Cancer—Metastatic
Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study Valentina Boni MD ABSTRACT: 210025 POSTER SESSION: Breast Cancer—Metastatic
Efficacy of lurbinectedin in a clinical trial versus other standard of care in a real-world comparator arm in relapsed/refractory small cell lung cancer patients Apar Kishor Ganti MD ABSTRACT: 208920 PUBLICATION ONLY: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Yondelis (trabectedin)
Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: Results of the expanded cohort of myxoid liposarcoma of the randomized clinical trial from the Italian Sarcoma Group (ISG), the Spanish Sarcoma Group (GEIS), the French Sarcoma Group (FSG), and the Polish Sarcoma Group (PSG) Alessandro Gronchi MD ABSTRACT: 208036 ORAL ABSTRACT SESSION: Sarcoma
Randomized phase III trial on trabectedin (ET-743) single agent versus clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal, or fallopian tube cancers of BRCA-mutated or BRCAness phenotype patients (MITO23) Giovanni Scambia MD ABSTRACT: 206849 ORAL ABSTRACT SESSION: Gynecologic Cancer
Trabectedin in advanced retroperitoneal well differentiated/dedifferentiated liposarcoma and leiomyosarcoma (TRAVELL): Results of a phase 2 study from Italian sarcoma group (ISG) Roberta Sanfilippo MD ABSTRACT: 211471 POSTER SESSION: Sarcoma