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Poster Display session

416 - Response rates with talimogene laherparepvec (T-VEC) monotherapy in patients (pts) with stage IIIB–IVM1c melanoma previously treated with checkpoint inhibitor (CPI) therapy: Retrospective analysis of two clinical trials


14 Dec 2018


Poster Display session


Helen Gogas


Annals of Oncology (2018) 29 (suppl_10): x17-x23. 10.1093/annonc/mdy486


H. Gogas1, R. Gutzmer2, J. Malvehy3, J.M. Mehnert4, K. Liu5, C.A. Pickett6, W. Snyder6, J. Chesney7

Author affiliations

  • 1 First Department Of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens School of Medicine, 10679 - Athens/GR
  • 2 Klinik Für Dermatologie, Allergologie Und Venerologie, Medizinische Hochschule Hannover (MHH), Hannover/DE
  • 3 Dermatology Department And Idibaps, Hospital Clinic of Barcelona, Barcelona/ES
  • 4 Melanoma And Soft Tissue Oncology Tumor Study Group, Rutgers Cancer Institute of New Jersey, New Brunswick/US
  • 5 Biostatististics, Amgen Inc., Thousand Oaks/US
  • 6 Clinical Research, Amgen Inc., Thousand Oaks/US
  • 7 James Graham Brown Cancer Center, University of Louisville, Louisville/US


Abstract 416


In the phase 3 OPTiM trial, intratumoral T-VEC (an oncolytic immunotherapy) significantly improved the overall response rate (ORR) vs GM-CSF in pts with unresectable Stage IIIB–IVM1c melanoma (26% vs 6%; p < 0.001). Treatment options for pts with unresectable or metastatic melanoma who have previously received CPI therapy are limited. This retrospective analysis evaluated response to T-VEC in pts who had received prior CPI therapy.


This analysis included data from two phase 2, single arm clinical trials of T-VEC monotherapy (Study 324 and Study 325). Both studies enrolled pts with unresectable or metastatic, stage IIIB–IVM1c melanoma, who were treated with T-VEC at the approved dose. Pts from these studies were included in the analysis if they had received prior pembrolizumab, nivolumab and/or ipilimumab (alone, sequentially or in combination).


Baseline characteristics of pts who had prior CPI therapy in Study 324 (N = 17)/Study 325 (N = 28), respectively, were: stage IIIB-IVM1a disease 71%/75%; BRAF wild-type 59%/61%; LDH ≤ULN 82%/75%. ORRs with T-VEC in Study 324 and Study 325 were 24% (4/17) and 21% (6/28), respectively (9 partial responses; 1 complete response; see Table). T-VEC-related adverse events (AEs) in CPI-experienced pts in Study 324/Study 325, respectively, were: Grade ≥3 AEs 18%/21%; serious AEs 18%/11%; AEs leading to permanent T-VEC discontinuation 12%/4%.Table: 60P

Response rates in pts who received ≥1 dose of T-VEC according to type of prior CPI therapy

Response with T-VEC,* n (%)Study 324Study 325
Prior pembrolizumab (N = 5)Prior nivolumab (N = 2)Prior ipilimumab (N = 15)Any prior CPI** (N = 17)Prior pembrolizumab (N = 7)Prior nivolumab (N = 9)Prior ipilimumab (N = 22)Any prior CPI** (N = 28)
Objective response1 (20)03 (20)4 (24)1 (14)1 (11)5 (23)6 (21)
Complete response (CR)001 (7)1 (6)0000
Partial response (PR)1 (20)02 (13)3 (18)1 (14)1 (11)5 (23)6 (21)
Disease control (CR/PR/stable disease)3 (60)08 (53)9 (53)3 (43)2 (22)9 (41)11 (39)

Tumor response, according to modified WHO criteria using both clinical assessment and radiological imaging, was assessed at Weeks 12, 24 and then every ≤3 months; Pembrolizumab, nivolumab and/or ipilimumab (alone, sequentially or in combination). Only one pt in Study 324 received prior combination ipilimumab/nivolumab and was unevaluable.


Although this retrospective analysis has limitations, the ORR with T-VEC in pts previously treated with a CPI was consistent with the ORR observed with T-VEC in the phase 3 OPTiM trial. Types and incidence of AEs were consistent with the known safety profile of T-VEC. These data suggest that T-VEC demonstrates measurable activity for melanoma pts who have received a prior CPI and have an injectable metastasis.

Editorial acknowledgement

Clinical trial identification

NCT02366195; NCT02014441.

Legal entity responsible for the study

Amgen Inc.


Amgen Inc.


H. Gogas: Advisor or consultant: Amgen, BMS, MSD, Novartis, Pierre Fabre, Roche. R. Gutzmer: Research support: J&J, Novartis & Pfizer; Consultant/served on speaker’s bureau: Almirall Hermal, Amgen, BMS, GSK, MSD, Novartis & Roche; Speaker’s bureau: Boehringer, Janssen, Merck-Serono, Pfizer. J. Malvehy: Consultant/advisor, honoraria: Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Merck Sharp & Dohme, Roche, Swedish Orphan Biovitrum. J.M. Mehnert: Research grants: Sanofi, Merck, EMD Serono, Novartis, Polyoma, AstraZeneca, Immunocore; Consulting fees: Merck; Advisory board: Boehringer Ingelheim. K. Liu: Employee of Amgen. C.A. Pickett, W. Snyder: Employee and stock holder: Amgen. J. Chesney: Consulting fees/honoraria, travel/accommodation expenses: Amgen; Scientific advisory board member and speakers bureau member: Amgen.

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