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281 JAVELIN Medley VEGF: phase 2 study of avelumab + axitinib in patients with previously treated non-small cell lung cancer (NSCLC) or treatment naive, cisplatin-ineligible urothelial cancer (UC)
  1. Gabriella Galffy1,
  2. Iwona Lugowska2,
  3. Elena Poddubskaya3,
  4. Byoung Chul Cho4,
  5. Myung-Ju Ahn5,
  6. Ji-Youn Han6,
  7. Wu-Chou Su7,
  8. Ralph Hauke8,
  9. Stephen Dyar9,
  10. Dae Ho Lee10,
  11. Piotr Serwatowski11,
  12. David Lorente Estelles12,
  13. Viran Holden13,
  14. Yu Jung Kim14,
  15. Vladimir Vladimirov15,
  16. Zsolt Horvath16,
  17. Abhimanyu Ghose17,
  18. Allison Goldman18,
  19. Alessandra di Pietro19,
  20. Jing Wang18,
  21. Danielle Murphy18 and
  22. Mikhail Laskov20
  1. 1Pulmonology Hospital Törökbálint, Torokbalint, Hungary
  2. 2Maria Sklodowska-Curie National Research, Warsaw, Poland
  3. 3Vitamed LLC, Moscow, Russian Federation
  4. 4Severance Hospital, Seoul, Korea, Republic of
  5. 5Samsung Medical Center, Seoul, Korea, Republic of
  6. 6National Cancer Center, Goyang, Korea, Republic of
  7. 7National Cheng Kung University Hospital, Tainan, Taiwan, Province of China
  8. 8Oncology Hematology West, Omaha, NE, USA
  9. 9Saint Francis Hospital Cancer Center, Greenville, SC, USA
  10. 10Asan Medical Center, Seoul, Korea, Republic of
  11. 11Centrum Medyczne Dom Lekarski S.A, Szczecin, Poland
  12. 12Consorcio Hospitalario, Castellon, Spain
  13. 13Oncology Hematology Associates, Springfield, MO, USA
  14. 14Seoul National University Bundang, Seongnam-si, Gyeonggi-do, Korea, Republic of
  15. 15GBUZ of Stavropol Territory, Pyatigorsk, Russian Federation
  16. 16Bacs-Kiskun Megyei Korhaz Onkoradiologia, Kecskemet, Hungary
  17. 17Arizona Oncology Associates, Tempe, AZ, USA
  18. 18Pfizer, Collegeville, PA, USA
  19. 19Pfizer Italia SRL, Milan, Italy
  20. 20LLC ‘University Clinic of Headache’, Moscow, Russian Federation


Background Avelumab, a human anti–PD-L1 monoclonal antibody, has shown a manageable safety profile and antitumor activity in multiple tumor types, including platinum-resistant metastatic or recurrent NSCLC,1 and is approved for patients with locally advanced or metastatic UC who have progressed after ≥1 previous line of platinum-based chemotherapy2 3 and as maintenance treatment for those who have not progressed with platinum-based chemotherapy.4 JAVELIN Medley VEGF (NCT03472560) evaluated the efficacy and safety of avelumab + axitinib, a potent inhibitor of VEGFR 1, 2, and 3, in patients with advanced or metastatic NSCLC or UC.

Methods Eligible patients with NSCLC had received ≥1 prior platinum-containing therapy and ≤2 prior lines of systemic therapy for locally advanced or metastatic disease; patients with UC were treatment naive in the locally advanced or metastatic setting and ineligible for cisplatin-containing chemotherapy. Patients were immune checkpoint inhibitor naïve and received avelumab 800 mg intravenously every 2 weeks + axitinib 5 mg orally twice daily. The primary endpoint was confirmed objective response (OR) per investigator assessment (RECIST 1.1). Secondary endpoints included progression-free survival (PFS) and safety. PD-L1 expression was assessed in baseline tumor samples (Ventana SP263 assay). Data have not undergone standard quality checks and are subject to change due to COVID-19–related healthcare burden.

Results A total of 41 patients with NSCLC and 20 with UC received avelumab + axitinib. The confirmed OR rate was 31.7% (95% CI, 18.1–48.1) in the NSCLC cohort and 10% (95% CI, 1.2–31.7) in the UC cohort (all partial responses); 16 patients (39.0%) and 5 (25.0%) had stable disease, respectively. Responses were observed regardless of PD-L1 expression status. Median PFS was 5.5 months (95% CI, 2.5–7.0) in the NSCLC cohort and 2.3 months (95% CI, 1.8–5.6) in the UC cohort. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 24 patients (58.5%) in the NSCLC cohort; the most common was hypertension (n=7 [17.1%]). Grade ≥3 TRAEs occurred in 9 patients (45.0%) in the UC cohort; the most common were amylase increased, asthenia, decreased appetite, and palmar-plantar erythrodysesthesia syndrome (n=2 [10%] each). One patient in each cohort experienced a TRAE that led to death (gastric perforation and urinary bladder hemorrhage).

Conclusions Avelumab + axitinib showed antitumor activity and a manageable safety profile in patients with advanced or metastatic NSCLC or UC consistent with findings from studies of each drug alone and in combination.

Trial Registration NCT03472560

Ethics Approval The study was approved by each site’s independent ethics committee.

Consent N/A


  1. Gulley JL, Rajan A, Spigel DR, et al. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol 2017;18:599–610.

  2. Patel MR, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol 2018;19:51–64.

  3. Bavencio(avelumab) injection. [package insert] Darmstadt, Germany: Merck KGaA; 2019.

  4. US Food and Drug Administration. FDA approves avelumab for urothelial carcinoma maintenance treatment. Accessed August 19, 2020.

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