Monday, July 11, 2016

Intralesional Therapy....and patterns of response from the T-VEC OPTiM trial

Y'all know I'm pretty stoked about various intralesional therapies...

There is this on Rose Bengal/PV-10:  Intralesional PV-10, positive treatment for in-transit melanoma (with a link to ASCO report within)

This on CAVATAK:  ASCO 2016: CAVATAK intralesional therapy derived from the coxsackie virus

And this (containing links to many articles) on T-VEC:  ASCO 2016: T-VEC/talimogene laherparepvec with pembro

Now there is this: 

Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial.  Andtbacka, Ross, Puzanov, et al.  Ann Surg Oncol. 2016 Jun 24.   

Talimogene laherparepvec (T-VEC) is an oncolytic immunotherapy designed to induce tumor regression of injected lesions through direct lytic effects, and of uninjected lesions through induction of systemic antitumor immunity. In this study, we describe the patterns and time course of response to T-VEC from the phase III OPTiM trial of 436 patients with unresected stages IIIB-IV melanoma.

Lesion-level response analyses were performed based on the type of lesion (injected or uninjected cutaneous, subcutaneous, or nodal lesions; or visceral lesions [uninjected]), and the best percentage change from baseline of the sum of products of the longest diameters was calculated. Patients randomized to T-VEC (n = 295) who experienced a durable response (continuous partial or complete response for greater/= to 6 months) were evaluated for progression prior to response (PPR), defined as the appearance of a new lesion or greater than 25 % increase in total baseline tumor area.

T-VEC resulted in a decrease in size by greater than/= to50 % in 64 % of injected lesions (N = 2116), 34 % of uninjected non-visceral lesions (N = 981), and 15 % of visceral lesions (N = 177). Complete resolution of lesions occurred in 47 % of injected lesions, 22 % of uninjected non-visceral lesions, and 9 % of visceral lesions. Of 48 patients with durable responses, 23 (48 %) experienced PPR, including 14 who developed new lesions only. No difference in overall survival was observed, and median duration of response was not reached in patients with PPR versus those without PPR.

Responses in uninjected lesions provide validation of T-VEC-induced systemic immunotherapeutic effects against melanoma. PPR did not negatively impact the clinical effectiveness of T-VEC.

For what it's worth.... - c

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