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Efficacy and safety of nivolumab (Nivo) + ipilimumab (Ipi) in patients (pts) with recurrent/metastatic (R/M) cervical cancer: Results from CheckMate 358

Date

29 Sep 2019

Session

Proffered Paper 2 – Gynaecological cancers

Presenters

Robert Naumann

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

R.W. Naumann1, A. Oaknin2, T. Meyer3, J.M. Lopez-Picazo4, C. Lao5, Y. Bang6, V. Boni7, W.H. Sharfman8, J.C. PARK9, L. Devriese10, K. Harano11, C.H. Chung12, S.L. Topalian13, K. Zaki14, T. Chen15, J. Gu15, B. Li16, A.M. Barrows17, A. Horvath18, K.N. Moore19

Author affiliations

  • 1 Ob/gyn, Levine Cancer Institute, NC 28204 - Charlotte/US
  • 2 Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 3 Oncology, UCL Cancer Institute, WC1E 6JD - London/GB
  • 4 Oncology Department, Clínica Universidad de Navarra, Navarra/ES
  • 5 Oncology, University of Michigan Comprehensive Cancer Center, 48103 - Ann Arbor/US
  • 6 Medical Oncology, Seoul National University Hospital, Seoul/KR
  • 7 Oncology, START Madrid CIOCC Hospital Madrid Norte Sanchinarro, 28050 - Madrid/ES
  • 8 Medical Oncology, Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Kimmel Cancer Center,, 21093 - Baltimore/US
  • 9 Medicine, Massachusetts General Hospital, 2114 - Boston/US
  • 10 Huispostnummer Q05.4.300 - Cancer Center Medische Oncologie, UMC Utrecht Cancer Center, Medische Oncologie, 3584 CX - Utrecht/NL
  • 11 Department Of Experimental Therapeutics, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 12 Head & Neck- Endocrine Oncology Department, H. Lee Moffitt Cancer Center University of South Florida, 33612 - Tampa/US
  • 13 Johns Hopkins University School Of Medicine, Bloomberg-Kimmel Professor of Cancer Immunotherapy, 21287-8934 - Baltimore/US
  • 14 Medical Oncology, University College London Hospital, NW1 2BU - London/GB
  • 15 Oncology, Bristol-Myers Squibb, Lawrence/US
  • 16 Biostatistics, Bristol-Myers Squibb, Princeton/US
  • 17 Oncology Clinical Development, Bristol-Myers Squibb, 08640 - Lawrenceville/US
  • 18 R&d, Bristol-Myers Squibb, 08640 - Lawrenceville/US
  • 19 Okc/sarah Cannon Research Institute, Stephenson Cancer Center at the University of Oklahoma, - - Nashville/US
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Background

High unmet medical need persists in pts with R/M cervical cancer; median overall survival (OS) is < 17 mo after 1L therapy with few options in 2L. Per current guidelines, pts whose tumors express programmed death ligand 1 (PD-L1) are eligible for pembrolizumab in the 2L setting. CheckMate 358 (NCT02488759) is an ongoing open-label, multi-cohort, phase I/II study of Nivo +/- Ipi in virus-associated cancers regardless of PD-L1 expression. Here we report an interim analysis of pts with R/M cervical cancer, with or without prior systemic therapies (PST), receiving Nivo + Ipi.

Methods

Eligible pts had R/M cervical cancer treated with 0-2 PST. Pts were randomized to Nivo 3mg/kg Q2W + Ipi 1mg/kg Q6W (Combo A), or Nivo 1mg/kg + Ipi 3mg/kg Q3W for 4 doses followed by Nivo 240mg Q2W (Combo B), for ≤24 mo until progression or unacceptable toxicity. Primary endpoint: investigator-assessed objective response rate (ORR) by RECIST 1.1; secondary endpoints: OS, progression-free survival (PFS) and duration of response.

Results

Median follow-up was 10.7 mo [Combo A, n = 45] and 13.9 mo [Combo B, n = 46]. ORR was higher in Combo B vs Combo A without PST (46% vs 32%) and with PST (36% vs 23%; Table). Median PFS in Combo A was 13.8 mo (95% CI 2.1, not reached [NR]) in pts without PST and 3.6 mo (1.9, 5.1) in pts with PST. Median PFS in Combo B was 8.5 mo (3.7, NR) without PST and 5.8 mo (3.5, 17.2) with PST. Median OS in Combo A was NR (17.4, NR) in pts without PST and 10.3 mo (7.9, 15.2) in pts with PST. Median OS in Combo B was NR without PST (13.9, NR) and 25.4 mo with PST (17.5, NR). Incidence of all/grade 3–4 treatment-related adverse events (AEs) was 80.0%/28.9% in Combo A and 82.6%/37.0% in Combo B. No new safety signals were identified.Table:

LBA62

Clinical response and efficacy
No prior systemic therapy for metastatic diseasePrior systemic therapy for metastatic disease
Combo ATotal n1926
Objective response rate, n (%)6 (31.6)6 (23.1)
Objective response rate, PD-L1* ≥1, responders/treated (%)4/13 (30.8)4/10 (40.0)
Objective response rate, PD-L1* <1, responders/treated (%)1/3 (33.3)1/11 (9.1)
Clinical benefit rate, n (%)12 (63.2)14 (53.8)
Median duration of response, months (95% CI)NR (6.6, NR)14.6 (7.5, NR)
PFS rate at 12 mo, %52.617.9
OS rate at 12 mo, %83.537.5
Combo BTotal n2422
Objective response rate, n (%)11 (45.8)8 (36.4)
Objective response rate, PD-L1* ≥1, responders/treated (%)4/11 (36.4)2/12 (16.7)
Objective response rate, PD-L1* <1, responders/treated (%)0/44/7 (57.1)
Clinical benefit rate, n (%)17 (70.8)16 (72.7)
Median duration of response, months (95% CI)NR (4.6, NR)9.5 (1.9, NR)
PFS rate at 12 mo, %43.538.1
OS rate at 12 mo, %78.084.7
*

Measured by tumor proportion score

Defined as the proportion of treated pts with a best overall response of confirmed complete response, partial response or stable disease

Conclusions

These results suggest clinical benefit from two regimens of Nivo + Ipi in pts with R/M cervical cancer regardless of PD-L1 status. Combo B had notable efficacy in pts with PST. AEs were manageable and consistent with previous reports of Nivo + Ipi therapy.

Clinical trial identification

NCT02488759.

Editorial acknowledgement

Writing and editorial assistance was provided by Brooke Middlebrook of Evidence Scientific Solutions Inc, and funded by Bristol-Myers Squibb.

Legal entity responsible for the study

Bristol-Myers Squibb, Princeton, NJ, USA.

Funding

Bristol-Myers Squibb, Princeton, NJ, USA.

Disclosure

R.W. Naumann: Research grant / Funding (institution): Bristol-Myers Squib; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Clovis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Genentech; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Janssen; Advisory / Consultancy, Research grant / Funding (institution): OncoMed; Advisory / Consultancy, Research grant / Funding (institution): SutroBio. A. Oaknin: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses, grant for VHIO: Pharma Mar; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses, grant for VHIO & VHIR: Clovis Oncology; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses, grant for VHIO: Tesaro; Advisory / Consultancy, Research grant / Funding (institution), grant for VHIO: Immunogen; Advisory / Consultancy: Genmab; Research grant / Funding (institution), VHIR: Abbie Deutchland; Research grant / Funding (institution), VHIO: Ability Pharmaceuticals; Research grant / Funding (institution), VHIO: Advaxis Inc; Research grant / Funding (institution), VHIR: Aeterna Zentaris; Research grant / Funding (institution), VHIR: Amgen SA; Research grant / Funding (institution), VHIO: Aprea Therapeutics AB; Research grant / Funding (institution), VHIO: Eisai Ltd; Research grant / Funding (institution), VHIO: F. Hoffmann - La Roche Ltd. ; Research grant / Funding (institution), VHIO: Regeneron Pharmaceuticals; Research grant / Funding (institution), VHIO: Merck Sharp & Dohme de España SA; Research grant / Funding (institution), VHIO: Millennium Pharmaceuticals Inc.. T. Meyer: Advisory / Consultancy: Beigene; Advisory / Consultancy: Merck; Advisory / Consultancy, Research grant / Funding (institution): BTG; Advisory / Consultancy: Eisai; Advisory / Consultancy: Ipsen; Research grant / Funding (institution): Bayer; Travel / Accommodation / Expenses, consultancy: BMS. C. Lao: Research grant / Funding (self), Travel / Accommodation / Expenses: BMS; Research grant / Funding (self): Genentech; Research grant / Funding (self): Merck; Research grant / Funding (self): Dynavax; Research grant / Funding (self): Novartis; Advisory / Consultancy: Immunocore. Y. Bang: Advisory / Consultancy: Hanmi; Advisory / Consultancy, Research grant / Funding (institution): Genexine; Advisory / Consultancy: Samyang Biopharm; Advisory / Consultancy, Research grant / Funding (institution): GreenCross; Advisory / Consultancy, Research grant / Funding (institution): BeiGene; Advisory / Consultancy, Research grant / Funding (institution): Astellas; Advisory / Consultancy, Research grant / Funding (institution): Daiichi-Sankyo; Advisory / Consultancy: Taiho; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Advisory / Consultancy, Research grant / Funding (institution): MSD; Advisory / Consultancy, Research grant / Funding (institution): Genentech/Roche; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer-Ingelheim; Research grant / Funding (institution): Curis; Research grant / Funding (institution): Taiho; Research grant / Funding (institution), Ono, CKD Pharma, Genexine Grant to Institution.: Takeda. V. Boni: Advisory / Consultancy: Loxo therapuetics; Advisory / Consultancy: Ideaya. W.H. Sharfman: Research grant / Funding (institution), personal fees: BMS; Research grant / Funding (institution), personal fees: Merck; Research grant / Funding (institution), personal fees: Novartis; Advisory / Consultancy: Iovance; Advisory / Consultancy: Regeneron. K. Harano: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Chugai; Advisory / Consultancy: Eizai; Advisory / Consultancy: Taiho; Advisory / Consultancy: Takeda. C.H. Chung: Honoraria (self), Received honorarium for ad hoc scientific advisory board participation: Bristol-Myers Squibb. S.L. Topalian: Shareholder / Stockholder / Stock options, Licensing / Royalties: Aduro Biotech; Advisory / Consultancy, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: Compugen; Advisory / Consultancy, Shareholder / Stockholder / Stock options: DNAtrix; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Dragonfly Therapeutics; Advisory / Consultancy, Shareholder / Stockholder / Stock options: ERVAXX; Advisory / Consultancy, Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options: Five Prime Therapeutics; Advisory / Consultancy, Shareholder / Stockholder / Stock options: FLX Bio; Shareholder / Stockholder / Stock options: Jounce Therapeutics; Research grant / Funding (institution), Shareholder / Stockholder / Stock options: Potenza Therapeutics; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Tizona Therapeutics; Advisory / Consultancy, Shareholder / Stockholder / Stock options: WindMIL; Advisory / Consultancy: AbbVie; Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Dynavax; Advisory / Consultancy, Licensing / Royalties: lmmunomic Therapeutics; Advisory / Consultancy: Janssen Oncology; Advisory / Consultancy: MedImmune; Advisory / Consultancy: Merck; Research grant / Funding (institution), Travel / Accommodation / Expenses, Licensing / Royalties: Bristol-Myers Squibb. T. Chen: Licensing / Royalties: Combination therapy with anti-IL-8 antibodies and anti-PD-1 antibodies for treating cancer. B. Li: Full/Part-time employment: Bristol-Myers Squibb. A.M. Barrows: Full / Part-time employment: Bristol-Myers Squibb. A. Horvath: Full / Part-time employment: Bristol-Myer Squibb. K.N. Moore: Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Immunogen; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Clovis; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Tesaro; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy: Janssen; Advisory / Consultancy: Aravive; Advisory / Consultancy: VBL Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Onco Med; Advisory / Consultancy: Samumed; Research grant / Funding (self), Research grant / Funding (institution): Lilly; Advisory / Consultancy: Eisai. All other authors have declared no conflicts of interest.

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