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Mini Oral - Investigational immunotherapy

1023MO - AMC 095: A report of nivolumab (nivo) in advanced HIV associated solid tumours (ST)

Date

18 Sep 2020

Session

Mini Oral - Investigational immunotherapy

Topics

Immunotherapy

Tumour Site

Presenters

Lakshmi Rajdev

Citation

Annals of Oncology (2020) 31 (suppl_4): S645-S671. 10.1016/annonc/annonc279

Authors

L. Rajdev1, S. Lensing2, J.C. Ramos3, R. Baiocchi4, C.J. Wang5, L. Ratner6, P.G. Rubinstein7, R. Ambinder8, D. Henry9, H. Streicher10, R.F. Little10, E. Chiao11, M.S. Lee12, D.P. Dittmer12, M.H. Einstein13, J.A. Sparano14, R.T. Mitsuyasu15

Author affiliations

  • 1 Medical Oncology, Lenox Hill Hospital, 10075 - NEW YORK/US
  • 2 Biostatistics, University of Arkansas for Medical Sciences, Little Rock/US
  • 3 Medical Oncology, University of Miami Sylvester Cancer Center, Miami/US
  • 4 Medical Oncology, Ohio State University James Comprehensive Cancer Center,, Columbus/US
  • 5 Medical Oncology, University of California, San Francisco, San Francisco/US
  • 6 Medical Oncology, Washington University, St Louis/US
  • 7 Medical Oncology, Ruth M Rothstein Core Center, Chicago/US
  • 8 Medical Oncology, Johns Hopkins Univ-Sidney Kimmel Cancer Center, Baltimore/US
  • 9 Medical Oncology, Pennsylvania Hospital, Philadelphia/US
  • 10 Investigational Drug Branch, National Cancer Institute, washington/US
  • 11 Medical Oncology, MD Anderson Cancer Center, Houston/US
  • 12 Medical Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill/US
  • 13 Obstetrics, Gynecology And Women’s Health, Rutgers New Jersey Medical School, Newark/US
  • 14 Medical Oncology, Montefiore Einstein Cancer Center, 10461 - Bronx/US
  • 15 Medical Oncology, Ronald Reagan UCLA Medical Cente, los angeles/US

Resources

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Abstract 1023MO

Background

Immune checkpoint blockade has emerged as a therapeutic strategy for cancers. The objective of this phase I study was to evaluate the safety/tolerability and describe immune-mediated effects of nivo in patients (pts) with HIV-associated ST.

Methods

Pts received nivo at 3 mg/kg q 2 wk, in two dose de-escalation cohorts stratified by CD4 count (Stratum 1: CD4 counts>200/uL and Stratum 2: CD4 count 100-200/uL) in pts with ST. An expansion cohort of 24 patients with CD4 count > 200 was then enrolled.

Results

A total of 37 pts were treated with nivo (n=4, 9, 24 for strata 1/2 and expansion cohorts). Histologies included Kaposi Sarcoma [KS](n=15), anal cancer [ca](n=5), lung ca (n=4) and other ST (n=13). No pts experienced dose-limiting toxicities (evaluable n=3 [stratum 1] and n=6 [stratum 2]). Treatment-related adverse events (AEs) were experienced by 14 (38%) pts. The most common treatment-related AEs were fatigue (n=5) and maculo-papular rash (n=4); of which, grade 3/4 severity was experienced by 2 pts each. Objective response rate (RR) by modified WHO criteria was 24% (9/37); with partial response (PR) in pts with KS (n=5), anal ca (n=1), colon ca (n=1), adenocarcinoma of the gall bladder (n=1), and squamous cell ca (n=1). There were no significant changes detected in HIV viral load (VL) during the study, which was undetectable for 97% of participants at baseline. Baseline median absolute CD4 was 315 (IQR, 225-434), and there was a trend for a reduction at 6-week (wk) post-treatment follow-up [f/u] (median difference: -35 (IQR, -83 to 37), p=0.072). Median CD4/CD8 ratio at baseline was 0.41 (IQR, 0.33-0.75) and increased by a median of 0.10 (IQR, -0.05 to 0.14, p=0.060) and 0.08 (IQR, 0 to 0.18, p=0.021) at 6- and 16 wk post-treatment f/u.

Conclusions

Nivo has acceptable safety in HIV patients with ST. Plasma viremia remained suppressed during the study suggesting no viral reactivation, and CD4/CD8 count ratio was increased at 16 wk post-treatment. A RR of 24% was observed in tumors known to be responsive to ICB. Thus, it is appropriate for HIV+ pts with ST treated with ART and a CD4+ T-cell count of greater than 100 cells/μL and undetectable VL to receive nivo in clinical trials and FDA-approved indications.

Clinical trial identification

NCT02408861.

Editorial acknowledgement

Legal entity responsible for the study

AMC (AIDS Malignancy Consortium).

Funding

NCI Grant #UM1CA121947.

Disclosure

L. Rajdev: Honoraria (self), Travel/Accommodation/Expenses: Bayer Pharmaceuticals. R. Baiocchi: Honoraria (self), Advisory/Consultancy, Leadership role, Research grant/Funding (self): Prelude Tx, Viracta. C-C.J. Wang, M.S. Lee: Research grant/Funding (institution): Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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