Thursday, January 12, 2017

Melanoma Big Dogs Pool their data for side effects with Nivolumab (Opdivo)

I put this together about anti-PD1 back in 2014:  Background and latest info on anti-PD1 for melanoma

Now melanoma big dogs have come together to publish this:

Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma. Weber, Hodi, Wolchok, Topalian, … Sznol, et al. J Clin Oncol. 2016 Nov 14.

We conducted a retrospective analysis to assess the safety profile of nivolumab monotherapy in patients with advanced melanoma and describe the management of adverse events (AEs) using established safety guidelines. Safety data were pooled from four studies, including two phase III trials, with patients who received nivolumab 3 mg/kg once every 2 weeks. We evaluated rate of treatment-related AEs, time to onset and resolution of select AEs (those with potential immunologic etiology), and impact of select AEs and suppressive immune-modulating agents (IMs) on antitumor efficacy. Among 576 patients, 71% experienced any-grade treatment-related AEs (most commonly fatigue [25%], pruritus [17%], diarrhea [13%], and rash [13%]), and 10% experienced grade 3 to 4 treatment-related AEs. No drug-related deaths were reported. Select AEs (occurring in 49% of patients) were most frequently skin related, GI, endocrine, and hepatic; grade 3 to 4 select AEs occurred in 4% of patients. Median time to onset of select AEs ranged from 5 weeks for skin to 15 weeks for renal AEs. Approximately 24% of patients received systemic IMs to manage select AEs, which in most cases resolved. Adjusting for number of doses, objective response rate (ORR) was significantly higher in patients who experienced treatment-related select AEs of any grade compared with those who did not. ORRs were similar in patients who did and patients who did not receive systemic IMs. Treatment-related AEs with nivolumab monotherapy were primarily low grade, and most resolved with established safety guidelines. Use of IMs did not affect ORR, although treatment-related select AEs of any grade were associated with higher ORR, but no progression-free survival benefit.

No real news here.   These adverse events and their rate of occurrence are consistent with what we have known for some time.  In this previous post Weber and Agarwala discuss: Side effects and how to manage them in targeted and immunotherapy for melanoma

There are many other posts regarding side effects on this blog including My Story and an ever evolving post of unusual and unfortunate Side effects to immunotherapy Part 6!

But ultimately....immunotherapy has given melanoma patients a fighting chance:  Nivolumab Shows Impressive OS in melanoma

All my best - c

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