2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Time: Sunday June 2, 8:00 AM to 11:00 AM
Location: Hall A
Phase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #398)
J Clin Oncol 37, 2019 (suppl; abstr 9075)
Author(s): Saiama Naheed Waqar, Mary Weber Redman, Susanne M. Arnold, Fred R. Hirsch, Philip C. Mack, Lawrence Howard Schwartz, David R. Gandara, Tom Stinchcombe, Natasha B. Leighl, Suresh S. Ramalingam, Saloni H. Tanna, Ryan S. Raddin, Katherine Minichiello, Karen Kelly, Jeffrey D. Bradley, Roy S. Herbst, Vassiliki Papadimitrakopoulou; Washington University School of Medicine, St. Louis, MO; SWOG Statistical Center; Fred Hutchinson Cancer Research Center, Seattle, WA; Markey Cancer Center, University of Kentucky, Lexington, KY; University of Colorado Cancer Center, Denver, CO; UC Davis Comprehensive Cancer Center, Sacramento, CA; Columbia University Medical College, New York, NY; University of California, Davis, Sacramento, CA; Duke Cancer Institute, Durham, NC; Princess Margaret Hospital, Toronto, ON, Canada; Winship Cancer Institute, Emory University, Atlanta, GA; Georgia NCORP/Oncology Specialists of Northeast Georgia, Gainsville, GA; Southeast COR NCORP/Bon Secours St. Francis Medical Center Cancer Institute, Midlothian, VA; University of California Davis Comprehensive Cancer Center, Sacramento, CA; Washington University School of Medicine in St. Louis, St. Louis, MO; Yale University School of Medicine, New Haven, CT; University of Texas MD Anderson Cancer Center, Houston, TX
Background: Lung-MAP is a platform trial to assess targeted therapies in SCC. S1400K was designed to evaluate the response to ABBV-399, an antibody-drug conjugate targeting C-MET, in patients with C-Met positive SCC. Methods: Patients with previously treated SCC with c-MET positive tumors (H score ≥150, Ventana SP44 assay), PS≤1, adequate organ function, peripheral neuropathy ≤ grade (G) 2, edema ≤ G2, albumin ≥3 g/dL, hepatic involvement by tumor < 50%. Patients were enrolled into 2 cohorts: Cohort 1 (immune checkpoint inhibitor (ICI) naïve) and cohort 2 (ICI refractory). ABBV-399 2.7 mg/kg was administered intravenously over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. Response assessments were performed every 6 weeks. The primary endpoint was response by RECIST 1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), response within cohort, duration of response (DoR), and toxicities associated with ABBV-399. Interim analysis was planned after 20 evaluable patients, with ≥ 3 responses needed to continue enrollment. Results: Between 2/15/18 and 10/16/2018, 50 patients (17% of patients screened) were assigned to S1400K, 28 patients enrolled (15 in cohort 1 and 13 in cohort 2), 25 were determined eligible, of whom 23 received ABBV-399 and were assessed for adverse events. There were 3 G5 events (2 pneumonitis, both in cohort 2 and 1 bronchopulmonary hemorrhage) and 4 G3 events. S1400K was temporarily closed on 10/16/2018 for interim analysis and safety concerns, and formally closed on 12/21/2018. Two responses were reported, both in cohort 1 (1 complete and 1 unconfirmed partial response, CR and UPR) for a response rate of 9% (95% CI: 0-20%). The CR remains on treatment at 4 months and DoR for the UPR was 2.3 months. Ten patients had stable disease and disease control rate was 52% (3-73%). The median OS and PFS were 4.7 and 2.4 months. Conclusions: ABBV-399 failed to meet the pre-specified response needed to justify continuing enrollment. Pneumonitis was an unanticipated toxicity observed in patients with SCC with previous immunotherapy exposure. Clinical trial information: NCT03574753