Online citations, reference lists, and bibliographies.
← Back to Search

Four-Year Survival Update For Metastatic Melanoma (MM) Patients (PTS) Treated With Ipilimumab (IPI) + Dacarbazine (DTIC) On Phase 3 Study CA184-024

M. Maio, I. Bondarenko, C. Robert, L. Thomas, C. Garbe, A. Testori, S. Francis, K. Chin, J. Wolchok
Published 2012 · Medicine

Cite This
Download PDF
Analyze on Scholarcy
ABSTRACT Background Data from clinical trials suggest a long-term survival effect (beyond 4 yrs) of IPI therapy in some pts with MM. An analysis of 177 pts from 3 phase I/II IPI studies conducted at NCI demonstrated 5-yr survival rates of 13-25% (Prieto, et al., CCR 2012). In other phase II trials, IPI monotherapy was associated with long-term survival of 4+ yrs in some pts with MM (Wolchok, et al., 2011 PIM). IPI in combination with DTIC in previously untreated MM patients significantly improved OS in phase III study CA184-024 (Robert, et al, NEJM 2011). Safety data from study 024 has been previously published. Here we report 4-yr survival data from study 024, the longest IPI survival follow-up from a phase III study. Table: 1127P Treatment group Median OS, months [95% CI] Overall survival rate, % [95% CI] 1-year 2-year 3-year 4-year IPI + DTIC N = 250 11.2 [9.4-13.6] 47.5% [41.2–53.8] 28.8% [23.2–34.6] 21.2% [16.1–26.5] 19.0% [14.2 - 24.2] Placebo + DTIC N = 252 9.1 [7.8-10.5] 36.4% [30.4–42.4] 17.8% [13.2–22.6] 12.1% [8.1–16.3] 9.6% [6.1 - 13.5] Methods Pts with treatment-naive MM were randomized to receive either IPI (10 mg/kg) + DTIC (850 mg/m2) or placebo + DTIC (850 mg/m2) given at Wks 1, 4, 7, 10 followed by DTIC q 3 wks through Wk 22. Pts with stable disease or better then received IPI or placebo q 12 wks as maintenance. This analysis reports OS with updated last known alive date or death date based on data collected through April 2012. Results The table summarizes median OS, previously reported survival rates at 1, 2, and 3 years, and current analyses for 4-year survival rates by treatment group. Conclusions The 4-year survival rates observed in an extended follow-up of a completed phase III trial suggests that IPI 10 mg/kg in combination with DTIC continues to demonstrate a survival benefit compared to the control arm. The continued survival of some patients at 4 yrs suggests that prolonged survival may indeed be obtained in some pts with treatment-naive MM. This observation of long-term survival benefit in a phase III RCT is consistent with observations from phase I/II studies of IPI in patients with advanced melanoma. Disclosure M. Maio: Paid advisor in boards from BMS and Roche. C. Robert: Consultant for BMS, GSK, Roche and Novartis. C. Garbe: I received honoraria and research funding from BMS. S. Francis: Employed by BMS. K. Chin: Employed by BMS and have Stock ownership. J. Wolchok: I am a consultant to BMS, Merck and GSK. I receive rsearch funding from BMS. All other authors have declared no conflicts of interest.

This paper is referenced by
Immunotherapy and malignant pleural mesothelioma
Timothy Allen (2018)
A health technology assessment of the new drugs for inoperable or metastatic malignant melanoma patients
E. Pike (2015)
Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials.
J. Wolchok (2013)
Multiple treatment comparison of seven new drugs for patients with advanced malignant melanoma: a systematic review and health economic decision model in a Norwegian setting
Eva Pike (2017)
Metastatic castration-resistant prostate cancer: new therapies, novel combination strategies and implications for immunotherapy
C. Drake (2014)
Ipilimumab for Previously Untreated Unresectable Malignant Melanoma: A Critique of the Evidence
C. Giannopoulou (2015)
Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study.
S. Slovin (2013)
Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: a multicenter, retrospective case series
S. Ravi (2014)
Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial.
L. Calabrò (2013)
Statistical issues and challenges in immuno-oncology
Tai-Tsang Chen (2013)
Non-BRAF-targeted therapy, immunotherapy, and combination therapy for melanoma
S. Tomei (2014)
Development of ipilimumab: a novel immunotherapeutic approach for the treatment of advanced melanoma
J. Wolchok (2013)
Semantic Scholar Logo Some data provided by SemanticScholar