Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display

1814 - Lurbinectedin (PM01183) plus paclitaxel (P), recommended dose (RD) expansion results with or without the addition of bevacizumab (Bev) in patients (pts) with selected solid tumors


10 Oct 2016


Poster display


Alexander Drilon


Annals of Oncology (2016) 27 (6): 114-135. 10.1093/annonc/mdw368


A. Drilon1, E. Garralda2, A. Stathis3, S. Szyldergemajn4, D. Hyman1, V. Boni2, G. Griguolo3, E. Jimenez Martinez4, V. Makker1, L. Canziani3, C. Fernandez Teruel4, A. Soto-Matos4, C. Sessa3, E. Calvo2

Author affiliations

  • 1 Oncology, Memorial Sloan Kettering Cancer Center, 10065 - New York/US
  • 2 Oncology, START-Madrid, Madrid/ES
  • 3 Oncology, IOSI-Ospedale San Giovanni, 6500 - Bellinzona/CH
  • 4 Clinical, PharmaMar, Colmenar Viejo/ES


Abstract 1814


The identified RD of PM01183 + P is PM01183 2.2 mg/m2 on Day (D)1 + P 80 mg/m2 D1&8 q3w. We provide updated results after RD expansion (A), and after Bev 15 mg/kg addition on D1 (B).


RECIST v1.1 evaluable pts ≤ 75 years (y) old, with ECOG PS 0-1, adequate organ function and ≤ 3 prior advanced lines were eligible. Prior taxanes were allowed if last dosed ≥ 3 months prior; prior weekly P or NAB-P were excluded. P was discontinued after 18 weeks and pts continued on PM01183 alone (A) or plus Bev (B). Pharmacokinetics (PK) was assessed in C1.


As of April 2016, 37/12 pts were treated (cohort A/B, accordingly); 2/37 and 3/12 experienced a dose-limiting toxicity (DLT) in Cycle 1, respectively. 32/10 were evaluable for efficacy. PK results were in line with published data.

Cohort n = pts DLT (%) ORR (95%CI) DOR months Tumor Type (%) CTC ARs G1-2 % CTC ARs G3 % CTC ARs G4 (%) Prior Taxanes Prior Bev
A (n = 37/32) Myelo suppression (5%) 40% (24-59) 4.2 (1.2-12.7+) NSCLC (16); SCLC (14), Breast (22); Endometrial (35), EOC (8) Other (5); Anemia Fatigue Nausea Vomiting Diarrhea PSN 72 57 51 43 22 35 Neutropenia Anemia ALT ↑ FN Thrombopenia Fatigue Rash Nausea Vomiting 28 22 11 3 3 3 3 3 3 Neutropenia (28) 57% 14%
B (n = 12/10) Myelo suppression (17%) Colonic Perforation (8%) 50% (19-81) 6.2 (2.4-10.9+) EOC (42) Non-squamous NSCLC (58) Anemia Fatigue Nausea Diarrhea Vomiting PSN 92 58 42 33 17 17 Neutropenia FN Anemia Fatigue Sepsis Colonic fistula 33 17 8 8 8 8 Neutropenia (25) Colonic perforation (8) 67% 25%

CI, confidence interval; CTCAE (v4.03), common toxicity criteria adverse reactions (related/unknown); EOC, epithelial ovarian cancer; G. grade; DOR; duration of response; NSCLC; non-small cell lung cancer; ORR, overall response rate; PSN; neurotoxicity; FN: febrile neutropenia


At the RD, PM01183/P has an acceptable safety profile and remarkable antitumor activity, even in pts previously exposed to taxanes/Bev. CSFs prophylaxis was not required at the RD. Neurotoxicity was not dose-limiting. The addition of Bev to PM01183/P RD was feasible but it seems more pts might experience DLTs in C1. No Drug-Drug Interactions were observed.

Clinical trial identification


Legal entity responsible for the study





S. Szyldergemajn, E. Jimenez Martinez, C. Fernandez Teruel, A. Soto-Matos: PharmaMar employee and stock ownership. D. Hyman: Consulting ATARA. E. Calvo: Consultan or Adviso: Astellas Ph, GlaxoSm, Janssen-Ci, Lilly, Novartis, Pfizer, PharmaMar, Roche/Ge, Sanofi Research Funding: All previous plus: Eisai, Merck Ser, Merck Sp & D, Millennium, OncoMed, Psi Oxus, Spectrum Ph Honoraria: Astellas Ph, Novartis. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings