Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Non-metastatic NSCLC and other thoracic malignancies

1984 - Initial Results of BMS-986012, a First-in-Class Fucosyl-GM1 mAb, in Combination With Nivolumab, in Pts With Relapsed/Refractory (rel/ref) Small-Cell Lung Cancer (SCLC)

Date

11 Sep 2017

Session

Non-metastatic NSCLC and other thoracic malignancies

Presenters

Quincy Siu-chung Chu

Citation

Annals of Oncology (2017) 28 (suppl_5): v539-v542. 10.1093/annonc/mdx386

Authors

Q.S. Chu1, C. van Herpen2, N.B. Leighl3, B. Markman4, S. Clarke5, R.A. Juergens6, P. Basciano7, D. Lathers7, S. Tannenbaum-Dvir7, K. Urbanska7, G. Kollia7, C. Darby7, D. Williams7, G. Kolaitis7, N. Ready8

Author affiliations

  • 1 Department Of Medical Oncology, Cross Cancer Institute, University of Alberta/Alberta Health Services, T6G 1Z2 - Edmonton/CA
  • 2 Department Of Medical Oncology, Radboud University Medical Center Nijmegen, 6525 GA - Nijmegen/NL
  • 3 Department Of Medical Oncology, Princess Margaret Cancer Centre, ON M5G1X6 - Toronto/CA
  • 4 Department Of Oncology, Monash Health and Monash University, 3168 - Melbourne/AU
  • 5 Department Of Medical Oncology, Royal North Shore Hospital, 2065 - St Leonards/AU
  • 6 Department Of Medical Oncology, Juravinski Cancer Centre, L8V 5C2 - Hamilton/CA
  • 7 Early Assets, Bristol-Myers Squibb, 08540 - Princeton/US
  • 8 Department Of Medicine, Duke University Medical Center, NC 27710 - Durham/US
More

Resources

Abstract 1984

Background

Given the burden of comorbidities, lack of curative agents, and high mortality in pts with SCLC, novel treatment options with limited toxicity are needed. BMS-986012 is a first-in-class, fully human mAb with enhanced antibody-dependent cell-mediated cytotoxicity that binds to fucosyl-GM1, a ganglioside highly expressed on SCLC. BMS-986012 monotherapy is well tolerated and has shown evidence of antitumor activity in some pts with rel/ref SCLC in a phase 1/2 study (NCT02247349; Chu et al. Ann Oncol. 2016;27(6 suppl) [abstract 1427PD]). Here we present initial results of BMS-986012 + nivolumab (anti–programmed death-1 mAb) in pts with rel/ref SCLC (NCT02247349).

Methods

Pts with SCLC who relapsed after or were refractory to first-line therapy received BMS-986012 400 or 1000 mg + nivolumab 360 mg IV Q3W. Dose escalation was based on a modified toxicity probability interval design. Primary objectives were safety and tolerability and determination of dose-limiting toxicities (DLT) and maximum tolerated dose. Secondary objectives included pharmacokinetics, antitumor activity, and immunogenicity.

Results

To date, 16 pts received BMS-986012 (400 mg, n = 8; 1000 mg, n = 8) + nivolumab. Demographic and safety data are based on 14 pts treated as of the April 3, 2017 cutoff. Median age was 64 y (range, 49-79 y), ECOG status was 0 (29%) or 1 (71%), and all pts were current (29%) or former (71%) smokers. All pts had prior platinum-based first-line therapy. The most common treatment-related AEs (TRAEs) were generalized pruritus (71%), vulvovaginal pruritus (21%), and dry skin (21%). Only 2 pts, both treated with 1000/360 mg, had G3/4 TRAEs (G3 pruritus with G4 lipase increase; G3 hepatic failure [DLT; led to discontinuation]). As of May 1, 2017, 4 of the 16 pts evaluable for efficacy achieved partial responses (2 unconfirmed). Updated efficacy data as well as data from ongoing biomarker analyses will be presented.

Conclusions

BMS-986012 in combination with nivolumab is well tolerated in pts with rel/ref SCLC, with no evidence of additive toxicity. Promising initial antitumor activity was observed with BMS-986012 + nivolumab in pts with rel/ref SCLC.

Clinical trial identification

NCT02247349

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

N.B. Leighl: Research funding (institution) - Novartis. Travel/honoraria (unrelated CME) - AstraZenenca, Pfizer, Bristol-Myers Squibb, Merck, Sharpe & Dohme. R.A. Juergens: BMS: advisory board member, honoraria, and grant support; clinical trials funding to my institution (outside of submitted work). P. Basciano, S. Tannenbaum-Dvir, D. Williams, G. Kolaitis: BMS employee; Owner of BMS stock. D. Lathers, K. Urbanska: BMS employee; Ownership of BMS stock. G. Kollia: BMS employee owning company stock. C. Darby: Employee of Mindlance, Inc. and working at Bristol-Myers Squibb under contract. N. Ready: Personal fees from Bristol Myers Squibb, Merck, Celgene, AstraZeneca, and Abbvie outside of submitted work. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.