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Patterns of durable response with intralesional talimogene laherparepvec (T-VEC): Results from a phase III trial in patients with stage IIIb-IV melanoma.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: T-VEC is an intralesional oncolytic immunotherapy comprising a modified HSV-type 1. In the randomized OPTiM phase 3 trial, T-VEC significantly improved DR rate (DRR, continuous partial or complete response for ≥6 mo) by 16% vs 2% and overall RR by 26% vs 6% vs subcutaneous (SC) GM-CSF in patients (pts) with advanced melanoma. We hypothesized that some pts progressed on treatment (tx) prior to DR and sought to determine how such events impacted the durability of response. Here we describe response patterns in T-VEC-treated pts with a DR. Methods: 436 pts with Stage IIIB-IV melanoma were randomized 2:1 to receive intralesional T-VEC or SC GM-CSF until clinically significant PD, intolerability, or lack of injectable lesions. Tx was to continue for at least 6 mo during which tx discontinuation for PD was not required. PD prior to response (PPR) was defined as the appearance of a new lesion or >25% increase in baseline tumor burden. Injection of new lesions was allowed. Responders were grouped as 1) PPR or 2) no PPR. PPR was grouped by a) existing lesions (± new lesions) or b) new lesions only. Pts without PPR were grouped by DR onset at ≤6 mo or >6 mo. Results: Of 48 T-VEC pts with a DR, 23 (48%) had PPR: 9 (39%) pts had PD in existing lesions (± new lesions) and 14 (61%) had new lesions only. For 25 pts with no PPR, 21 (84%) had a DR beginning within the first 6 mo. 40 (83%) of the DRs remain in remission with a median follow up of over 18.4 mo. Conclusions: Similar to other immunotherapies, PPR was common in T-VEC-treated pts. Most PPRs included the development of new lesions, thus T-VEC tx should continue through PD. The quality of DR does not seem to be negatively affected by PPR or the timing of achieving DR. These data reinforce the evolving new paradigm of response criteria when treating pts with melanoma with immunotherapeutic agents. Clinical trial information: NCT00769704.
|Median (Min, Max) time to DR (mo)a||3.1 (1.2, 9.5)||5.8 (1.3, 10.6)|
|Median (Min, Max) duration of DR (mo)||NE (6.2+, NE)||NE (6.3, NE)|
|DR maintained at end of follow-up, n (%)b||22 (88%)||18 (78%)|
aP=0.004, Wilcoxon rank sum test; bP=0.27, log rank test; NE, Not evaluable, median not reached; +censored.
Abstracts by Merrick I. Ross:
A phase I/II study of lymphodepletion plus adoptive cell transfer (ACT) with T cells transduced with CXCR2 and NGFR followed by high dose interleukin-2 (IL-2) in patients with metastatic melanoma (MM).Meeting: 2016 ASCO Annual Meeting | Abstract No: TPS9594Category: Melanoma/Skin Cancers - Advanced Disease
Meeting: 2016 ASCO Annual Meeting
| Abstract No: TPS9600
Category: Melanoma/Skin Cancers - Local-Regional
Preliminary results from phase II study of combination treatment with HF10, a replication-competent HSV-1 oncolytic virus, and ipilimumab in patients with stage IIIb, IIIc, or IV unresectable or metastatic melanoma.Meeting: 2016 ASCO Annual Meeting | Abstract No: 9543Category: Melanoma/Skin Cancers - Advanced Disease