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2019 ASCO Annual Meeting!

Session: Melanoma/Skin Cancers

Type: Poster Session

Time: Monday June 3, 1:15 PM to 4:15 PM

Location: Hall A

Long-term follow-up of CA209-004: A phase I dose-escalation study of combined nivolumab (NIVO) and ipilimumab (IPI) in patients with advanced melanoma.

Advanced Disease

Melanoma/Skin Cancers

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #104)

J Clin Oncol 37, 2019 (suppl; abstr 9533)

Author(s): Michael B. Atkins, John M. Kirkwood, Jedd D. Wolchok, Margaret K. Callahan, Harriet M. Kluger, Michael A. Postow, Neil Howard Segal, Alexander M. Lesokhin, Agnes Balogh, Sandra Re, Mario Sznol; Georgetown Lombardi Comprehensive Cancer Center, Washington, DC; University of Pittsburgh Medical Center, Pittsburgh, PA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY; Yale School of Medicine and Smilow Cancer Center, Yale New Haven Hospital, New Haven, CT; Bristol-Myers Squibb, Princeton, NJ

Abstract Disclosures


Background: We previously reported a 3-year overall survival (OS) rate of 63% with NIVO+IPI concurrent therapy in the initial phase I dose-escalation study for the combination, conducted in patients (pts) with advanced melanoma. Here, we report OS after 5 years of overall study follow-up and assess survival rates after stopping treatment. Methods: Adults with previously treated or untreated unresectable stage III or IV melanoma, and ECOG performance status of 0 or 1, received NIVO + IPI Q3W × 4 as mg/kg in one of the following cohorts: (1) NIVO 0.3 + IPI 3; (2) NIVO 1 + IPI 3; (2a) NIVO 3 + IPI 1; (3) NIVO 3 + IPI 3; (8) NIVO 1 + IPI 3. Cohorts 1-3 received maintenance with NIVO Q3W × 4, then NIVO + IPI Q12W × 8 at assigned doses; cohort 8 received NIVO Q2W for up to 96 weeks. Patients were followed for the primary endpoint of safety and the secondary endpoints of response and progression-free survival for up to 2.5 years, then for the survival exploratory endpoint for up to an additional 3 years, for a maximum study participation of 5.5 years. Results: At a median follow-up of 43.1 months (range 0.9-76.7) in all cohorts (N = 94), the 4- and 4.5-year OS rates were both 57% (95% CI: 47, 67). The 4-year OS rates for pts with normal (n = 58) versus elevated LDH (n = 36) were 62% (48, 74) versus 49% (32, 65); for pts with wild-type (n = 66) and mutant (n = 24) BRAF tumors, 4-year OS rates were 54% (41, 65) and 61% (38, 77), respectively. Following the last dose of study drug (for any reason), overall post-treatment 1-, 2-, and 3-year OS rates were 74% (64, 82), 65% (55, 74), and 56% (46, 66), respectively; in pts who discontinued due to study drug toxicity (n = 32), post-treatment 1-, 2-, and 3-year OS rates were 84% (66, 93), 75% (55, 86), and 65% (45, 79), respectively, and in pts who discontinued for disease progression (n = 30), these were 52% (33, 68), 34% (18, 51), and 24% (11, 41), respectively. Conclusions: This updated analysis from study CA209-004 showed favorable survival outcomes with NIVO+IPI, regardless of BRAF or LDH status, and provided evidence of long-term survival following discontinuation of treatment in pts with advanced melanoma. Clinical trial information: NCT01024231

Other Abstracts in this Sub-Category:


1. Phase 3 international trial of adjuvant whole brain radiotherapy (WBRT) or observation (Obs) following local treatment of 1-3 melanoma brain metastases (MBMs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9500 First Author: Gerald Fogarty
Category: Melanoma/Skin Cancers - Advanced Disease


2. Efficacy and safety of the combination of nivolumab (NIVO) plus ipilimumab (IPI) in patients with symptomatic melanoma brain metastases (CheckMate 204).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9501 First Author: Hussein Abdul-Hassan Tawbi
Category: Melanoma/Skin Cancers - Advanced Disease


3. Salvage therapy after failure from anti-PD-1 single agent treatment: A Study by the German ADOReg melanoma registry.

Meeting: 2019 ASCO Annual Meeting Abstract No: 9505 First Author: Michael Weichenthal
Category: Melanoma/Skin Cancers - Advanced Disease