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Advanced melanoma: association between complete response and survival in patients treated with Talimogene laherparepvec plus Ipilimumab


This is the first randomized trial testing the addition of an oncolytic virus to an immune checkpoint inhibitor for advanced melanoma.

At the 3-year follow-up, the combination ( combo ) of Talimogene laherparepvec ( T-VEC; Imlygic ) and Ipilimumab ( Yervoy ) has demonstrated durable and statistically superior objective response rate ( ORR ) over Ipilimumab alone ( 36.7% versus 16.0%; odds ratio, OR=3.0; 95% Cl, 1.6–6.0; P = 0.002 ).
Complete response ( CR ) rate was 21.4% with the combination and 6.0% with Ipilimumab.
Median overall survival ( OS ) was not reached in either arm.

In this post hoc analysis, researchers have utilized the 3-year landmark data to explore the relationship between complete response and overall survival in the combo arm.

Patients with unresectable, stage IIIB-IV melanoma were randomized 1:1 to receive Talimogene laherparepvec + Ipilimumab or Ipilimumab alone.

Talimogene laherparepvec was administered intratumorally on day 1 of week 1 at 106 plaque-forming units ( PFU )/mL followed by subsequent doses at 108 PFU/mL on day 1 of week 4, and every 2 weeks thereafter.
Ipilimumab ( 3 mg/kg ) was given every 3 weeks starting on day 1 of week 6 for up to 4 doses.
Response was assessed by investigators per immune-related response criteria every 12 weeks until disease progression.

The primary endpoint was objective response rate; key secondary endpoints were overall survival, progression-free survival ( PFS ), and safety.

198 patients were randomized ( 98 to Talimogene laherparepvec + Ipilimumab; 100 to Ipilimumab ). As of February 25, 2019, the median follow-up time was 40.0 months ( range: 0.2–63.7 ) for the combo arm.

Among 98 patients who received Talimogene laherparepvec + Ipilimumab, 21 ( 21.4% ) had a best overall response of CR including 8 who converted from an initial partial response ( PR ), 15 ( 15.3% ) had PR, 19 ( 19.4% ) had stable disease, 30 ( 30.6% ) had progressive disease, and 13 ( 13.2% ) were unevaluable.

Of 21 patients achieving CR, 17 ( 81% ) had ECOG status of 0, 16 ( 76.2% ) had stage IIIB-IVM1a disease, and 16 ( 76.2% ) had no visceral metastases.

Median duration of CR was not reached ( range: 5.4[+]–58.2[+] months ); 19 of 21 complete responses lasted more than 6 months.

The baseline tumor burden was lower in patients with CR than in those with non-CR.

Median overall survival was not reached in patients with CR ( range: 25.1[+]–63.7[+] months ) and was 47.6 months ( range: 0.2[+]– 63.7[+] months ) in patients with non-CR ( Log-rank P = 0.0005 ). The Kaplan–Meier estimated 3-year OS rate was 100.0% for patients with CR and 52.3% for those with non-CR.

In conclusion, CR rate was higher with Talimogene laherparepvec plus Ipilimumab than with Ipilimumab alone in patients with advanced melanoma ( 21.4% vs 6.0% ).
In the combo arm, CR was associated with prolonged overall survival, and patients with CR tended to have better ECOG performance status, earlier-stage disease, and lower baseline tumor burden, as compared with those with non-CR. ( Xagena )

Source: American Society of Clinical Oncology ( ASCO ) Virtual Meeting, 2020

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