Lurbinectedin (LUR) in combination with Irinotecan (IRI) in patients (pts) with advanced endometrial carcinoma.

• DOI: 10.1200/jco.2021.39.15_suppl.5586
• Publication Date: 2021-06-02T14:15:18Z
• Authors: Alejandro Falcon ...; Luis G. Paz-Ares; Gregory Michael Cote; Santiago Ponce Aix; Julia Martinez; Elizabeth Jimenez...; Elena Brehcist; Rafael Nuñez; Jesus R Fernandez; Sonia Extremera; Carmen Maria Kahatt; Ali Hassan Zeaiter; Inmaculada Sanche...
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

5586 Background: LUR is a new agent that exerts antitumor activity through inhibition of trans-activated transcription and modulation tumor microenvironment. Preclinical synergism/additivity in combination with IRI has been reported, thus prompting the conduct this trial. This synergism had evaluated recently reported patients Small Cell Lung Cancer, encouraging results (Ponce et al. WCLC, 2020). Methods: Phase I trial to evaluate escalating doses on Day (D) 1 plus fixed dose 75 mg/m 2 D1 D8 every 3 weeks (q3w) pts advanced solid tumors, enrolled following standard 3+3 escalation design. II expand selected indications at Recommended Dose (RD). In abstract, cohort endometrial carcinoma treated RD presented. Results: 21 (all female) were (LUR mg/m2 + G-CSF); 57% ECOG PS=1; median age was 64 years (range 34-74); subtype tumour split: 67% (14 pts) endometroid, 33% non-endometroid (3 serous-papilar, clear-cell pt undifferentiated); prior lines (range, 1−7) per pt. Common G1/2 toxicities nausea, vomiting, fatigue, diarrhea anorexia; G3/4 hematological comprised neutropenia (33%), thrombocytopenia (5%) anemia (38%). Two episodes febrile occurred (9.5%). non consisted (24%), asthenia (19%), nausea (14%) vomiting (5%), all transient manageable. patient discontinued treatment due toxicity drug-related (generalized muscular weakness), but no treatment-related deaths reported. Objective RECIST responses documented 4/21 evaluable (19%). With 6 censored for progression, PFS 4.4 months (95% CI 2.1-9.6 months), 40.4%. The clinical benefit rate (% Complete Response (CR), Partial (PR) or Stable Disease > 4 months) 43%, Control Rate CR, PR SD) 81%. 3/21 have more than 12 so far. Conclusions: Lurbinectedin Irinotecan active heavily pretreated carcinoma. well-tolerated consistent known safety profile combination. Myelosuppression, diarrhea, predictable Updated will be presented meeting. Clinical information: NCT02611024.