Monday, February 27, 2017

Ipi plus peginterferon = 45% rate of AE's and 45% ORR

Taking interferon alone has proven to be a dismal treatment option as was noted here: 

For Stage II/III melanoma patients: Interferon NO BETTER than observation!!!! be fair...there was this....

A phase IB study of ipilimumab with peginterferon alfa-2b in patients with unresectable melanoma.   Brohl, Khushalani, Eroglu...Weber. J Immunother Cancer. 2016 Dec 20.

Ipilimumab and peginterferon alfa-2b are established systemic treatment options for melanoma that have distinct mechanisms of action. Given the need for improved therapies for advanced melanoma, we conducted an open-label, single institution, phase Ib study to assess the safety and tolerability of using these two agents in combination.Study treatment consisted of ipilimumab given every 3 weeks, for a total of four infusions, concurrent with peginterferon alfa-2b administered subcutaneous weekly for a total of 12 weeks. This was followed by maintenance therapy with peginterferon alfa-2b administered subcutaneously weekly for up to 144 additional weeks. The study was designed as a two-stage dose escalation scheme with continuous dose-limiting toxicity monitoring during the induction phase.  Thirty one patients received at least 1 dose of study treatment and 30 were assessable for efficacy endpoints. We found that ipilimumab at 3 mg/kg dosing with peginterfeon alfa-2b at 2 μg/kg/week was the maximum tolerated dose of this combination. The incidence of grade 3 drug-related adverse events (AEs) was 45.2%. There were no grade 4/5 AEs. The overall response rate was 40% by immune-related response criteria. Median progression-free survival was 5.9 months. The median overall survival was not reached with at a median follow-up of 35.8 months.  We report that the combination of ipilimumab at 3 mg/kg dosing combined with peginterfeon alfa-2b at 2 μg/kg/week demonstrated an acceptable toxicity profile and a promising efficacy signal. Further study of this combination is warranted.

Guess I'm just not clear on why you would want to experience a higher rate of adverse effects in order to attain results that may not be quite as good as those we can already attain with anti-PD-1 as a single agent??????  Maybe if you hadn't attained a response with Opdivo or Keytruda?  But, if possible, why not try the ipi/nivo combo with it's 50-plus % response rate???

For what it's worth! - c

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