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Poster Display session 3

2664 - Phase (Ph) II study of MBG453 + spartalizumab in patients (pts) with non-small cell lung cancer (NSCLC) and melanoma pretreated with anti–PD-1/L1 therapy


30 Sep 2019


Poster Display session 3



Tumour Site

Melanoma;  Non-Small Cell Lung Cancer


Nicholas Mach


N. Mach1, G. Curigliano2, A. Santoro3, D. Kim4, D.W.M. Tai5, S. Hodi6, S. Wilgenhof7, T. Doi8, T. Longmire9, H. Sun10, A. Xyrafas11, S. Gutzwiller11, L. Manenti10, C. Lin12

Author affiliations

  • 1 Cancer Centre, Geneva University Hospitals, 1211 - Geneva/CH
  • 2 Early Drug Development for Innovative Therapies Division, Istituto Europeo di Oncologia IRCCS, University of Milan, 20141 - Milan/IT
  • 3 Irccs Humanitas Cancer Center, Humanitas University, Milan/IT
  • 4 Department Of Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 5 Division Of Medical Oncology, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 6 Melanoma Center And Center For Immuno-oncology, Dana Farber Cancer Institute, Boston/US
  • 7 Department Of Medical Oncology, Antoni van Leeuwenhoek, Amsterdam/NL
  • 8 Department Of Experimental Therapeutics, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 9 Translational Clinical Oncology, Novartis Institutes for BioMedical Research, Cambridge/US
  • 10 Translational Clinical Oncology, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 11 Translational Clinical Oncology, Novartis Pharma AG, Basel/CH
  • 12 Department Of Oncology, National Taiwan University Hospital, 10002 - Taipei/TW


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Abstract 2664


MBG453 and spartalizumab are humanized IgG4 mAbs that block binding of TIM-3 to PtdSer and PD-1 to PD-L1/2, respectively. In Ph I dose escalation, MBG453 + spartalizumab showed preliminary antitumor activity in advanced solid tumors. Here we report Ph II MBG453 + spartalizumab dose expansion in pts with NSCLC and melanoma (NCT02608268).


Pts with melanoma or NSCLC who had progressive disease (PD) on/after anti–PD-1/L1 therapy received MBG453 (800 mg, Q4W) + spartalizumab (400 mg, Q4W) until unacceptable toxicity, PD, or investigator/pt decision. On prior anti–PD-1/L1 therapy clinical benefit (CB) was defined as durable (DCB) if pts had a complete or partial response, or stable disease (SD) for ≥6 months, or non-durable (NDCB) if pts had SD for <6 months or PD.


As of Feb 15, 2019, 33 pts received MBG453 + spartalizumab (melanoma: n=16; NSCLC: n=17); 5 (15.2%) pts were ongoing (melanoma: n=3 [18.8%]; NSCLC: n=2 [11.8%]); 28 (84.8%) pts discontinued, mainly due to PD (60.6%) and death due to underlying disease (12.1%). Anti–PD-1/L1 was the last therapy before enrollment in 21 (63.6%) pts (melanoma: n=10 [62.5%]; NSCLC: n=11 [64.7%]). On prior anti–PD-1/L1 therapy, 6 (37.5%) melanoma and 7 (41.2%) NSCLC pts had DCB and 10 (62.5%) melanoma and 9 (52.9%) NSCLC pts had NDCB; CB was unknown (UNK) in 1 NSCLC pt. On MBG453 + spartalizumab, 3/16 (18.8%) melanoma pts (prior anti-PD-1/L1: DCB n=2; NDCB n=1) and 7/17 (41.2%) NSCLC pts (prior anti-PD-1/L1: DCB n=3; NDCB n=3; UNK n=1) had SD per RECIST 1.1. Baseline tumor PD-L1 appears higher in pts with SD vs PD. Data suggest a trend of inverse association between tumor reduction and CD163 tumor expression. Common treatment-related adverse events (TRAEs) were fatigue, nausea, and pruritus (n=3 each [9.1%]); 0 melanoma and 2 (11.8%) NSCLC pts (pruritus, amylase, lipase, and increased ALT) had Grade 3/4 TRAEs.


MBG453 (800 mg, Q4W) + spartalizumab (400 mg, Q4W) was well tolerated but with limited efficacy in pts with melanoma and NSCLC who had PD on/after prior anti–PD-1/L1 therapy. Further evaluation of MBG453 in other indications/combinations is needed to assess the clinical relevance of TIM-3 inhibition.

Clinical trial identification

Editorial acknowledgement

Editorial assistance was provided by Jenny Winstanley, PhD, of Articulate Science Ltd.

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