Are we expecting to hear anything about the Galaxy-1 results presented at the WCLC meeting on Saturday, Oct. 26th (or will it be on Monday AM at 8am)? Can anybody confirm?
Synta Pharmaceuticals Corp. (SNTA) today announced that results from the GALAXY-1 trial, which evaluates the Company’s lead drug candidate ganetespib in patients with advanced non-small cell lung adenocarcinoma, will be presented during an oral session at the 15th World Conference on Lung Cancer (WCLC) in Sydney, Australia:
“Randomized Phase II study of docetaxel with or without ganetespib in advanced lung adenocarcinoma: Results in biomarker sub-groups and all adenocarcinoma patients”
Abstract #: O03.01
Session: Oral Abstract Session, NSCLC – Targeted Therapies I
Date and time: Monday, October 28. 10:30 AM – 12:00 PM local time
Location: Bayside Auditorium B, Level 1
Presenter: Suresh Ramalingam, M.D., Winship Cancer Institute, Emory University, Atlanta, GA
Results will be presented from the analysis planned for one year from the last patient enrolled in the 253-patient primary enrollment phase of GALAXY-1. The Company expects to release these results on Saturday, October 26, 2013, concurrent with the beginning of the WCLC meeting.
Based upon the number of overall survival events, Synta expects that the final overall survival analysis of GALAXY-1 will be conducted by early 2014.
O03.01 | GALAXY-1: Randomized phase II study of docetaxel with or without ganetespib in advanced lung adenocarcinoma: Results in biomarker sub-groups and all adenocarcinoma patients.
Authors: Suresh S. Ramalingam1, Geoffrey Shapiro2, Vera Hirsh3, Bojan Zaric4, Timur Ceric5, Elena Poddubskaya6, Jonathan Goldman7, Tudor Ciuleanu8, Fadlo R. Khuri1, James Spicer9, Olga Skrylnik10, Enriqueta Felip11, Christian Manegold12, Zoran Andric13, Rafael Rosell14, Sonja Badovinac15, Thierry Pieters16, Manuel R. Modiano17, Vojislav M. Vukovic18, Ilker Yalcin18, Florentina Teofilovici18, Iman El-Hariry18, Wei Guo18, Safi R. Bahcall18, Glenwood Goss19, Dean Fennell20
1Winship Cancer Institute of Emory University, Atlanta/UNITED STATES OF AMERICA, 2Dana Farber Cancer Institute, Boston/UNITED STATES OF AMERICA, 3McGill University Health Center, Montreal/CANADA, 4Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica/SERBIA, 55Clinical Center University of Sarajevo, Sarajevo/BOSNIA AND HERZEGOVINA, 6Unit of Russian Academy of Medical Sciences, Blokhin Russian Oncology Research Center, Moscow/RUSSIAN FEDERATION, 7UCLA, Santa Monica, California/UNITED STATES OF AMERICA, 8Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj/ROMANIA, 9King's College, London/UNITED KINGDOM, 10Municipal Institution Dnipropetrovsk City Multispecialty Clinical Hospital #4, Dneproptrovsk/UKRAINE, 11Hospital Valle Hebron, Barcelona/SPAIN, 12Klinikum Mannheim GmbH, Mannheim/GERMANY, 13Clinical Hospital Centre Bezanijska kosa, Belgrade/SERBIA, 14Catalan Institute Of Oncology, Badalona/SPAIN, 15Clinical Hospital Centre Zagreb, Zagreb/CROATIA, 16Clinique Universitaires Saint-Luc, Brussels/BELGIUM, 17ACRC/Arizona Clinical Research Center, Tucson/UNITED STATES OF AMERICA, 18Synta Pharmaceuticals, Lexington/UNITED STATES OF AMERICA, 19Ottawa Hospital Centre, Ottawa/CANADA, 20University of Leicester, Leicester/UNITED KINGDO
Ganetespib (G) is a highly potent 2nd-generation Hsp90 inhibitor showing synergistic activity with docetaxel (D) in NSCLC xenografts. G has a favorable clinical safety profile and has shown single-agent clinical activity in NSCLC patients with tumors harboring EML4-ALK translocations and KRAS mutations (mKRAS).
We conducted a randomized, international open-label Phase 2 study of D with or without G in patients with advanced lung adenocarcinoma, one prior systemic therapy, and ECOG PS 0/1. D was given at 75 mg/m2 on Day 1 of a three-week cycle in both arms. In the combination arm, G was given at 150 mg/m2 on Days 1 and 15. The co-primary endpoints were PFS in patients with elevated LDH (eLDH) levels, or tumors harboring KRAS mutation. Key secondary endpoints were OS and PFS in all adenocarcinoma patients. Target enrollment was 240 adenocarcinoma patients, including 120 eLDH and 80 mKRAS patients. The study was initiated in all NSCLC patients and amended to include only those with adenocarcinoma histology.