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2017 ASCO Annual Meeting!

Session: Melanoma/Skin Cancers

Type: Oral Abstract Session

Time: Sunday June 4, 8:00 AM to 11:00 AM

Location: Arie Crown Theater

Efficacy and safety of nivolumab (NIVO) plus ipilimumab (IPI) in patients with melanoma (MEL) metastatic to the brain: Results of the phase II study CheckMate 204.

Advanced Disease

Melanoma/Skin Cancers

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr 9507)

Author(s): Hussein Abdul-Hassan Tawbi, Peter A. J. Forsyth, Alain Patrick Algazi, Omid Hamid, F. Stephen Hodi, Stergios J. Moschos, Nikhil I. Khushalani, Rene Gonzalez, Christopher D. Lao, Michael Andrew Postow, Michael B. Atkins, Marc S. Ernstoff, Igor Puzanov, Ragini Reiney Kudchadkar, Reena Parada Thomas, Ahmad A. Tarhini, Joel Jiang, Alexandre Avila, Sheena Demelo, Kim Allyson Margolin; The University of Texas MD Anderson Cancer Center, Houston, TX; Moffitt Cancer Center and Research Institute, Tampa, FL; University of California, San Francisco, San Francisco, CA; The Angeles Clinic and Research Institute, Los Angeles, CA; Dana-Farber Cancer Institute, Boston, MA; University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; University of Colorado Comprehensive Cancer Center, Aurora, CO; University of Michigan, Ann Arbor, MI; Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical College, New York, NY; Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Roswell Park Cancer Institute, Buffalo, NY; Winship Cancer Institute, Atlanta, GA; Stanford University Hospital, Palo Alto, CA; University of Pittsburgh Medical Center, Pittsburgh, PA; Bristol-Myers Squibb, Princeton, NJ; Department of Medical Oncology, City of Hope, Duarte, CA

Abstract Disclosures


Background: Brain metastases (BMts) are a major cause of morbidity/death in MEL. We report the first efficacy data in MEL patients (pts) with BMts who received NIVO+IPI in study CheckMate 204. Methods: In this multicenter US trial (NCT02320058), MEL pts with ≥1 measurable BMt 0.5-3.0 cm and no neurologic symptoms or steroid Rx received NIVO 1 mg/kg + IPI 3 mg/kg Q3W x 4, then NIVO 3 mg/kg Q2W until progression or toxicity. Pts with severe adverse events (AEs) during NIVO+IPI could receive NIVO when toxicity resolved; stereotactic radiotherapy (SRT) was allowed for brain oligo-progression if an assessable BMt remained. The primary endpoint was intracranial (IC) clinical benefit rate (complete response [CR] + partial response [PR] + stable disease [SD] > 6 months). The planned 90-pt accrual is complete; we report efficacy and updated safety for 75 pts with disease assessment before the Nov 2016 database lock. Results: Median age was 59 yrs (range 22–79). Median number of induction doses was 3; 26 pts (35%) received 4 NIVO+IPI doses and 38 pts (51%) began NIVO maintenance. Response data are reported at a median follow-up of 6.3 months (Table). The IC objective response rate (ORR) was 56% (95% CI: 44–68); 19% of pts had a complete response. IC and extracranial responses were largely concordant. Rx-related grade 3/4 AEs occurred in 48% of pts, 8% neurologic, including headache and syncope. Only 3 pts (4%) stopped Rx for Rx-related neurologic AEs. One pt died of immune-related myocarditis. Conclusions: In CheckMate 204, prospectively designed to investigate NIVO+IPI in MEL pts with BMts, NIVO+IPI had high IC antitumor activity with objective responses in 56% of pts, CR in 19%, and no unexpected neurologic safety signals. The favorable safety and high anti-melanoma activity of NIVO+IPI may represent a new Rx paradigm for pts with asymptomatic MEL BMts and could change practice to avoid or delay whole brain RT or SRT. Clinical trial information: NCT02320058

Best overall response,
n (%, 95% CI)
    CR2 (3, 0–9)14 (19, 11–29)4 (5, 1–13)
    PR40 (53, 41–65)28 (37, 26–49)33 (44, 33–56)
    SD >6 months5 (7, 2–15)6 (8, 3–17)2 (3, 0–9)
ORR, n (%, 95% CI)42 (56, 44–68)42 (56, 44–68)37 (49, 38–61)

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Meeting: 2017 ASCO Annual Meeting Abstract No: 109 First Author: Patrick Alexander Ott
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2. REGN2810: A fully human anti-PD-1 monoclonal antibody, for patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC)—Initial safety and efficacy from expansion cohorts (ECs) of phase I study.

Meeting: 2017 ASCO Annual Meeting Abstract No: 9503 First Author: Kyriakos P. Papadopoulos
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3. Long-term outcomes in patients (pts) with ipilimumab (ipi)-naive advanced melanoma in the phase 3 KEYNOTE-006 study who completed pembrolizumab (pembro) treatment.

Meeting: 2017 ASCO Annual Meeting Abstract No: 9504 First Author: Caroline Robert
Category: Melanoma/Skin Cancers - Advanced Disease