Abstract 3311
Background
Microsatellite instability-high (MSI-H) is observed in a large variety of cancer types. Immune checkpoint targeted therapies against PD-1 and CTLA-4 have demonstrated significant activity in metastatic colorectal cancer (mCRC) with nivolumab +/- ipilimumab. We aimed to demonstrate a clinical benefit of nivolumab in non-CRC MSI patients.
Methods
The AcSé immunotherapy program launched by the French National Cancer Institute (INCa) and sponsored by the French network of comprehensive cancer centers (Unicancer) is a nationwide exploratory program which has allowed access to anti-PD-1 therapies outside of their current approvals. A phase II, single arm, AcSé-nivolumab trial has been conducted to investigate the efficacy and tolerance of nivolumab in patients with metastastic/refractory rare tumor types. Here we report the results of the MSI cohort. Nivolumab (240 mg IV) was administered q2w for a max of 2 years or until disease progression (PD), or toxicity. The primary endpoint was the objective response rate (ORR) assessed by RECIST v1.1 at 12 weeks.
Results
From July 2017 to October 2018, 50 pts (mean age 63 years) were included. Primary locations were endometrial adenoCa (17), gastric (10), small bowel (7), pancreas (5), biliary (4), urothelial (2), ovary (2), and breast (2). 15 patients (30%) had a Lynch syndrome. All patients were pre-treated (mean of previous lines: 1.6) and had a MSI status locally determined by IHC and/or PCR (IHC 15 pts, PCR 4, both 31). The mean number of cycles/patients was 12.9. The ORR at 12 weeks was 38% (95%CI 24.6 to 52.8) and the best ORR at any time was 42% (95%CI, 28.2 to 56.8) with median time to response of 14 weeks. CR: n = 2; PR: n = 17; SD: n = 16; DCR=74%. Median PFS was not reached with a 6-mo PFS at 58.9% (95%CI, 46.5 to 74.6). At the date of analysis, 15 patients died (PD 13, drug related death 1, other 1), with a 6-mo OS rate at 80.3% (95%CI, 69.5 to 92.8). No unexpected adverse event of nivolumab has been observed.
Conclusions
Nivolumab as monotherapy is highly active in non-colorectal MSI patients, outperforming results of classical chemotherapy in this heavily pre-treated population.
Clinical trial identification
NCT03012581, EudraCT 2016-002257-37.
Editorial acknowledgement
Legal entity responsible for the study
R&D UNICANCER.
Funding
La Ligue Nationale Contre le Cancer, Institut National du Cancer (INCa), BMS La Ligue Contre le Cancer, INCa, BMS.
Disclosure
C. Tournigand: Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (institution), Travel / Accommodation / Expenses: MSD; Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (institution), Travel / Accommodation / Expenses: BMS. E. Saada-Bouzid: Advisory / Consultancy: BMS; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Merck Serono. D. Pouessel: Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Sanofi; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: Astellas; Advisory / Consultancy, Research grant / Funding (institution): Janssen; Research grant / Funding (institution): MSD; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): A2; Speaker Bureau / Expert testimony: Ipsen; Speaker Bureau / Expert testimony: BMS. C. Le Tourneau: Advisory / Consultancy: MSD; Advisory / Consultancy: BMS; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Nanobiotix; Advisory / Consultancy: Roche; Advisory / Consultancy: Amgen; Advisory / Consultancy: GSK. P. Augereau: Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneca. J. Soria: Advisory / Consultancy, Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca; Shareholder / Stockholder / Stock options: Gritstone; Advisory / Consultancy: Astex; Advisory / Consultancy: Clovis; Advisory / Consultancy: GSK; Advisory / Consultancy: GammaMabs; Advisory / Consultancy: Lilly; Advisory / Consultancy: MSD; Advisory / Consultancy: Mission Therapeutics; Advisory / Consultancy: Merus; Advisory / Consultancy: Pfizer; Advisory / Consultancy: PharmaMar; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Roche/Genentech; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Servier; Advisory / Consultancy: Symphogen; Advisory / Consultancy: Takeda. A. Marabelle: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): BMS; Research grant / Funding (self): Boehringer Ingelheim; Research grant / Funding (self): Fondation MSD Avenir; Advisory / Consultancy: Oncovir; Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck Serono; Advisory / Consultancy: eTheRNA; Advisory / Consultancy, Research grant / Funding (self): Lytix pharma; Advisory / Consultancy: Kyowa Kirin Pharma; Advisory / Consultancy: Novartis, Seattle Genetics, Molecular Partners; Advisory / Consultancy: Symphogen, Bayer, Partner Therapeutics; Advisory / Consultancy: Genmab, RedX pharma, OSE Immunotherapeutics; Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen, Sanofi, Servier; Advisory / Consultancy: Biothera, Gritstone; Advisory / Consultancy: Nektar, Pierre Fabre; Advisory / Consultancy: GSK; Advisory / Consultancy: Oncosec; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Speaker Bureau / Expert testimony, Research grant / Funding (self): MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): AstraZeneca/MedImmune; Speaker Bureau / Expert testimony, Research grant / Funding (self): Roche/Genentech. All other authors have declared no conflicts of interest.
Resources from the same session
4096 - Patient experience and use of an intervention combining nurse-led telephone and technologies for the monitoring of oral cancer medication
Presenter: Marie Ferrua
Session: Poster Display session 3
Resources:
Abstract
6042 - Harnessing nurse leadership to implement a project for electronic scheduling of chemotherapy
Presenter: Emma Masters
Session: Poster Display session 3
Resources:
Abstract
3123 - Turkish Cancer Patients’ Preference for Information and Communication Technologies
Presenter: Esra ildes
Session: Poster Display session 3
Resources:
Abstract
6062 - Unmet Needs in Oncology Research related to radiological response evaluation: a multi-center survey in three European countries
Presenter: Sophie Nisse Durgeat
Session: Poster Display session 3
Resources:
Abstract
6109 - A program implementation to facilitate intraoperative brachytherapy between hospitals
Presenter: Marc Garcia Casellas
Session: Poster Display session 3
Resources:
Abstract
1772 - Using Mobile-Based Health Care Applications Outcomes: Mini Systematic Review
Presenter: Aydanur Aydin
Session: Poster Display session 3
Resources:
Abstract
2792 - Evaluation of an education program for cancer patients receiving chemotherapy
Presenter: Iraqi Amina
Session: Poster Display session 3
Resources:
Abstract
3715 - iGestSaúde: Application for self-management of symptoms during chemotherapy treatment
Presenter: Bruno Magalhaes
Session: Poster Display session 3
Resources:
Abstract
3854 - Palliative care requirements of cancer patients and investigation of knowledge and expectations related to palliative care of the patients and their families
Presenter: Ozlem Topkaya
Session: Poster Display session 3
Resources:
Abstract
4997 - Hospice care, what to expect? An exploration of the expectation of future hospice patients
Presenter: Merel van Klinken
Session: Poster Display session 3
Resources:
Abstract