Axitinib With Avelumab Shows Promise as First-Line Therapy for Renal Cell Carcinoma

Share this content:
Researchers enrolled 6 and 49 patients into dose-finding and dose expansion stages, respectively.
Researchers enrolled 6 and 49 patients into dose-finding and dose expansion stages, respectively.

Avelumab/axitinib combination therapy demonstrated promising antitumor activity and safety in treatment-naive patients with advanced renal cell carcinoma (RCC), according to a study published in The Lancet Oncology.1

For the phase 1b JAVELIN Renal 100 study ( Identifier: NCT02493751), researchers enrolled 6 and 49 patients into dose-finding and dose expansion stages, respectively. Eligible patients had advanced RCC with a clear-cell component, were treatment-naive, and had undergone primary tumor resection.

Patients enrolled in the dose-finding stage received oral axitinib monotherapy twice daily for 1 week, followed by intravenous avelumab every 2 weeks plus axitinib twice daily. The median follow-up was 69.7 weeks.

Continue Reading Below

Grade 3 or 4 treatment-related adverse events (AEs), including hypertension, lipase concentration increase, mucosal inflammation, and proteinuria, were observed in 4 of 6 patients. Only grade 3 proteinuria was, however, dose-limiting. The maximum tolerated dose was defined at avelumab 10 mg/kg every 2 weeks and axitinib 5 mg twice daily.

All included patients experienced at least 1 AE; 53 patients (95%) experienced AEs determined to be treatment-related. Thirty-two (58%) patients experienced grade 3 or worse AEs, including diarrhea, hypertension, infusion-related reactions, palmar-plantar erythrodysesthesia syndrome, increased alanine aminotransferase and aspartate aminotransferase concentration, immune-related AEs, and rash.

Five (9%) patients died because of disease progression and 1 (2%) because of treatment-related autoimmune myocarditis.

All 6 patients in the dose-finding arm and 26 (53%) patients in the dose expansion arm had a confirmed objective response.

The authors concluded that “the overall response and durability of responses in our study are encouraging and warrant further study of this drug combination.” A phase 3 study assessing avelumab plus axitinib vs sunitinib as first-line therapy is ongoing.


  1. Choueiri TK, Larkin J, Oya M, et al. Preliminary results for avelumab plus axitinib as first-line therapy in patients with advanced clear-cell renal-cell carcinoma (JAVELIN Renal 100): an open-label, dose-finding and dose expansion, phase 1b trial. Lancet Oncol. 2018 Mar 9. Doi: 10.1016/S1470-2045(18)30107-4 [Epub ahead of print]

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs