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PRO 140 CCR5 Monoclonal Antibody Strong in Highly Pretreated People: Week 25
- (ICAAC 2017 June 1)
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Expanded Access Program for ibalizumab in Resistant HIV-1 - (05/17/17)
ASM 2017/ICAAC, June 1-5, 2017, New Orleans
Mark Mascolini
All 9 trial participants who completed a week of PRO 140 monotherapy then 24 weeks of PRO 140 plus an optimized background regimen had an undetectable (target-not-detected) HIV load at week 25 despite multidrug resistance and heavy pretreatment [1]. The injected humanized CCR5 monoclonal antibody caused no serious adverse events or dropouts because of adverse events.
Despite the potency of current antiretroviral combinations, some people with heavy antiretroviral experience harbor multidrug-resistant HIV that does not respond to licensed agents. PRO 140 is a humanized CCR5 monoclonal antibody that blocks HIV attachment to the CCR5 coreceptor on T cells. In an earlier study, PRO 140 monotherapy pushed viral loads below 40 copies for more than 40 weeks in 13 of 16 participants (81%) [2].
The new study, PRO 140_CD02, began with a 1-week phase in which participants got a single 350-mg subcutaneous shot of PRO 140 or placebo on top of their failing background regimen. Everyone had HIV that used only the CCR5 coreceptor, and everyone had virus resistant to multiple antiretroviral classes. Part 2 is an ongoing open-label trial in which participants in the monotherapy study take PRO 140 at a dose of 350 mg once weekly plus an optimized background regimen for 24 weeks.
The 23 study participants had a median age of 54 years and had an HIV diagnosis for 23 years. Eighteen participants (78%) were men, 7 (30%) were non-Caucasian, and 5 (22%) were Hispanic.
Two people dropped out of the study, one because the infecting viral population also used a coreceptor other than CCR5, and one because of withdrawn consent. Follow-up in the 24-week phase was continuing in 12 people at the time of this report. Among 9 participants who completed 24 weeks of PRO 140 plus an optimized regimen, all had a target-not-detectable reading on their viral load assay. Eight of these 9 people have continued PRO 140 in an extension study.
This trial and two PRO 140 monotherapy studies are ongoing. In these trials there have been no drug-related serious adverse events with PRO 140, no discontinuations because of adverse events, and no discernible pattern of toxicity. Injection site reactions were infrequent, mild, and transient. So far there have been no dose-limiting toxicities.
References
1. Dhody K, Maddon PJ, Kazempour K, et al. Interim results of PRO 140 in a phase 2b/3 study in treatment-experienced HIV-1 patients with multiple ARV class resistance. ASM 2017/ICAAC, June 1-5, 2017, New Orleans. Session 273.
2. Lalezari J, Dhody K, Kowalczyk U, et al. PRO140 single-agent maintenance therapy for HIV-1 infection: a 2-year update. CROI 2017. February 14-16, Seattle. Abstract 437. http://www.natap.org/2017/CROI/croi_129.htm
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Interim Results in a Phase 2b/3 Pivotal Study of PRO 140 in Treatment Experienced HIV-1 Patients with Multiple ARV Class Resistance
Reported by Jules Levin
ICAAC / ASM Microbe 2017
June 3, 2017 - New Orleans
K. Dhody1, P. J. Maddon2, K. Kazempour1, N. Pourhassan3, D. Green1,D. Burger3;
1Amarex Clinical Res., LLC, Germantown, MD,2Maddon Advisors LLC, Scarsdale, NY,3CytoDyn Inc, Vancouver, WA,
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