Poster Presentation COSA 2015 ASM

Nivolumab (Nivo) monotherapy or in combination with ipilimumab (Ipi) for treatment of recurrent small cell lung cancer (SCLC) (#187)

Emiliano Calvo 1 , Jose López-Martin 2 , Johanna Bendell 3 , Joseph P Eder 4 , Matthew Taylor 5 , Patrick A Ott 6 , M Catherine Pietanza 7 , Leora Horn 8 , Dirk Jäger 9 , Filippo de Braud 10 , Michael A Morse 11 , Paolo A Ascierto 12 , Dung T Le 13 , Asim Amin 14 , Jeff Evans 15 , Jason S Simon 16 , Chen-Sheng Lin 16 , Olaf Christensen 16 , Scott J Antonia 17
  1. START Madrid, Centro Integral Oncológico Clara Campa , Madrid, Spain
  2. Hospital Universitario 12 de Octubre, Madrid, Spain
  3. Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, USA
  4. Yale Cancer Center, New Haven, CT, USA
  5. Oregon Health & Science University, Portland, OR, USA
  6. Dana-Farber Cancer Institute, Boston, MA, USA
  7. Memorial Sloan-Kettering Cancer Centre, New York, NY, USA
  8. Vanderbilt University Medical Center, Nashville, TN, USA
  9. Heidelberg University Hospital, Heidelberg, Germany
  10. Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
  11. Duke University Medical Centre, Durham, NC, USA
  12. Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy
  13. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA
  14. Levine Cancer Institute, Charlotte, NC, USA
  15. Beatson West of Scotland Cancer Centre, Glasgow, UK
  16. Bristol-Myers Squibb, Princeton, NJ, USA
  17. H. Lee Moffitt Cancer Centre & Research Institute, Tampa, FL, USA

Aim: To present updated results of a phase 1/2 study of nivolumab (N) alone or in combination with ipilimumab (I) in pretreated patients with SCLC.

Methods: Patients with progressive disease, regardless of platinum sensitivity, tumor programmed death ligand-1 expression, or number of prior chemotherapy regimens, were assigned to intravenous N 3 mg/kg Q2W or N+I (1+1 mg/kg or 1+3 mg/kg) Q3W for 4 cycles, followed by N 3 mg/kg Q2W. Primary objective was overall response rate (ORR). Additional objectives included safety, progression-free survival, overall survival, and biomarker analysis.

Results: Ninety patients were enrolled (N, n=40; N1+I1, n=3; N1+I3, n=47); 53% had ≥2 prior regimens. ORR was 18% (7/39), 33% (1/3), and 17% (7/42) in the N, N1+I1, and N1+I3 arms, respectively, with corresponding median durations of response of 4.1–11+, 11.1+, and 1.5–6.9+ months. Eight patients (20%) in the N arm, 1 (33%) in the N1+I1 arm, and 20 (43%) in the N1+I3 arm remain on treatment. Three patients (8%) treated with N, zero with N1+I1, and 5 (11%) with N1+I3 discontinued due to treatment-related adverse events (TRAEs). Grade 3–4 TRAEs occurred in 6 patients (15%) with N (stomatitis, fatigue, amylase increase, g-glutamyl transpeptidase increase, hyperglycemia, encephalitis in 1 patient each), zero patients with N1+I1, and 16 patients (34%) with N1+I3 (in ≥2 pts [4%]: diarrhea 8.5%, increased lipase 6.4%, vomiting 4.3%, rash 4.3%, rash maculo-papular 4.3%, and dermatitis 4.3%). Two patients (grade 1–2) in the N arm and 1 (grade 3–4) in the N1+I3 arm experienced treatment-related pneumonitis. One fatal case of treatment-related myasthenia gravis occurred in the N1+I3 arm.

Conclusions: Patients with SCLC treated with N or N+I achieved durable responses after progressing on platinum-based therapy. The safety profile was consistent with that observed in other tumors, and was manageable with established safety guidelines.