Journal article
Efficacy and safety results from a phase III trial of nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naive patients (pts) with advanced melanoma (MEL) (CheckMate 067).
- Wolchok, Jedd D. Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY
- Chiarion-Sileni, Vanna Oncology Institute of Veneto IRCCS, Padua, Italy
- Gonzalez, Rene University of Colorado Cancer Center, Denver, CO
- Rutkowski, Piotr Maria Sklodowska-Curie Memorial Cancer Center & Institute of Oncology, Warsaw, Poland
- Grob, Jean Jacques Hospital de la Timone, Marseille, France
- Cowey, Charles Lance Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX
- Lao, Christopher D. University of Michigan, Ann Arbor, MI
- Schadendorf, Dirk Department of Dermatology, University of Essen, Essen, Germany
- Ferrucci, Pier Francesco European Institute of Oncology, Milan, Italy
- Smylie, Michael Cross Cancer Institute, Edmonton, AB, Canada
- Dummer, Reinhard Universitäts Spital, Zurich, Switzerland
- Hill, Andrew Graham Tasman Oncology Research, Queensland, Australia
- Haanen, John B. A. G. Netherlands Cancer Institute, Amsterdam, Netherlands
- Maio, Michele University Hospital of Siena, Siena, Italy
- McArthur, Grant A. Peter MacCallum Cancer Centre, East Melbourne, Australia
- Yang, Arvin Bristol-Myers Squibb, Princeton, NJ
- Rollin, Linda Bristol-Myers Squibb, Wallingford, CT
- Horak, Christine E. Bristol-Myers Squibb, Princeton, NJ
- Larkin, James M. G. Royal Marsden Hospital, London, United Kingdom
- Hodi, F. Stephen Dana-Farber Cancer Institute, Boston, MA
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2015, vol. 33, no. 18_suppl, p. LBA1-LBA1
English
LBA1 Background: The results of a phase I study in MEL suggested complementary clinical activity with NIVO (a PD-1 checkpoint inhibitor) plus IPI (a CTLA-4 checkpoint inhibitor). Here, we report the results of a randomized, double-blind, phase III trial designed to evaluate NIVO combined with IPI or NIVO alone vs IPI alone in MEL. Methods: Treatment-naïve pts (N = 945) were randomized 1:1:1 to NIVO 1 mg/kg Q2W + IPI 3 mg/kg Q3W for 4 doses followed by NIVO 3 mg/kg Q2W, NIVO 3 mg/kg Q2W + placebo, or IPI 3 mg/kg Q3W for 4 doses + placebo, until progression or unacceptable toxicity. Pts were stratified by PD-L1 status, BRAF mutation status, and M-stage. Co-primary endpoints are progression-free survival (PFS) (reported here) and overall survival (pts continue to be followed). Secondary endpoints include objective response rate (ORR) by RECIST v1.1 and safety. Results: At a minimum follow-up of 9 months, NIVO + IPI and NIVO alone significantly improved PFS and ORR vs IPI (Table). Grade 3-4 drug-related adverse events (AEs) occurred in 55.0%, 16.3%, and 27.3% of pts in the NIVO + IPI, NIVO, and IPI arms, respectively (most commonly diarrhea [9.3%, 2.2%, 6.1%], increased lipase [8.6%, 3.5%, 3.9%], increased alanine aminotransferase [8.3%, 1.3%, 1.6%], and colitis [7.7%, 0.6%, 8.7%]). Drug-related AEs led to discontinuation in 36.4%, 7.7%, and 14.8% of pts in the NIVO + IPI, NIVO, and IPI arms, with 0, 1, and 1 drug-related deaths, respectively. Efficacy outcomes by PD-L1 status will also be presented. Conclusions: NIVO + IPI and NIVO alone had superior clinical activity vs IPI alone. The results with NIVO + IPI and NIVO alone further suggest complementary activity of the two agents. There were no new safety signals or drug-related deaths observed with the combination. Clinical trial information: NCT01844505. [Table: see text]
- Language
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- English
- Open access status
- closed
- Identifiers
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- DOI 10.1200/jco.2015.33.18_suppl.lba1
- ISSN 0732-183X
- Persistent URL
- https://folia.unifr.ch/global/documents/18509
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