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Poster display session

1785 - Meta-Analysis of Anti-PD-1/PD-L1 Therapy Related Adverse Events in Clinical Trials

Date

10 Sep 2017

Session

Poster display session

Presenters

Yucai Wang

Citation

Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376

Authors

Y. Wang1, X. Wang2, F. Yang2, X. Guan2, N. Duma1, J. Vera Aguilera1, G.S. Nowakowski3, A.V. Chintakuntlawar1, K.A. Price1, J.R. Molina1, T.R. Halfdanarson1, A. Grothey1, S.N. Markovic1

Author affiliations

  • 1 Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 2 Medical Oncology, Medical School of Nanjing University, 210002 - Nanjing/CN
  • 3 Hematology, Mayo Clinic, 55905 - Rochester/US
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Resources

Abstract 1785

Background

Anti-PD-1/PD-L1 immunotherapy is a major breakthrough in cancer treatment. With increasing use, its adverse event (AE) profile continues to be defined. We performed a meta-analysis to summarize AEs of anti-PD-1/PD-L1 therapy in clinical trials.

Methods

Clinical trials involving monotherapy with PD-1 or PD-L1 antibody in cancer patients published before April 1, 2017 were reviewed, and treatment related AE data were extracted. Meta-analysis of AE rates was done by Comprehensive Meta-Analysis (v2) using a random effects model. Average AE rate (Total AE No./Total Patient No.) was calculated in Microsoft Excel.

Results

63 studies involving 10592 patients were included: 27 on nivolumab, 23 on pembrolizumab, 8 on atezolizumab, 4 on avelumab, and 1 on BMS-936559. Treatment related AE rates were summarized in the Table. In meta-analysis, all grade AE (AEx) rate was 71.5%, and grade 3-4 AE (AE3) rate was 14.9%. Common AEx included fatigue (>20%), pruritus, rash, diarrhea, nausea (10-20%), decreased appetite, arthralgia, vitiligo, pyrexia, hypothyroidism, and asthenia (5-10%). Most common AE3 included hyponatremia, lymphopenia, and fatigue (>1%). Average immune-mediated AEx/AE3 rates (%) were uveitis 0.9/0.0, pneumonitis 2.9/0.8, colitis 1.4/0.9, ALT increase 3.7/0.9, AST increase 4.0/0.8, pancreatitis 1.7/0.4, vitiligo 8.2/0.1, alopecia 1.0/0.0, asthenia 7.3/0.4, paresthesia 1.0/0.0, dysgeusia 2.2/0.0, peripheral neuropathy 1.5/0.0, hypothyroidism 7.0/0.1, hyperthyroidism 3.0/0.1, hypophysitis 0.5/0.4, and adrenal insufficiency 1.2/0.5. 31 (0.3%) treatment related deaths were reported. Pulmonary causes were most common, including 11 pneumonitis, 3 pneumonia and 1 respiratory failure.

Conclusions

Common AEs of anti-PD-1/PD-L1 therapy were primarily constitutional and gastrointestinal. Most grade 3-4 AE rates were < 1%. Rates of immune-related AE were low. Treatment related death was rare, and pneumonitis was the most common cause.

Clinical trial identification

Not applicable.

Legal entity responsible for the study

Yucai Wang

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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