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

The Lancet Oncology

Volumn 18, Issue 5, 2017, Pages 599-610

  Gulley, James L ^a   Rajan, Arun ^a   Spigel, David R ^b   Iannotti, Nicholas ^c   Chandler, Jason ^d   Wong, Deborah J L ^e   Leach, Joseph ^f   Edenfield, W Jeff ^g   Wang, Ding ^h   Grote, Hans Juergen ⁱ   Heydebreck, Anja von ⁱ   Chin, Kevin ^j   Cuillerot, Jean Marie ^j   Kelly, Karen ^k  

^a NATIONAL CANCER INSTITUTE   (United States)

^b SARAH CANNON RESEARCH INSTITUTE   (United States)

^c Hematology Oncology Associates of Treasure Coast   (United States)

^d Hematology Oncology   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f Virginia Piper Cancer Institute   (United States)

^g Institute for Translational Oncology Research   (United States)

^h HENRY FORD HOSPITAL   (United States)

ⁱ MERCK KGAA   (Germany)

^j EMD Serono   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMINOTRANSFERASE; AMYLASE; AVELUMAB; GAMMA GLUTAMYLTRANSFERASE; TRIACYLGLYCEROL LIPASE; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; PLATINUM DERIVATIVE;

ADRENAL INSUFFICIENCY; ADULT; AGED; AMINOTRANSFERASE BLOOD LEVEL; AMYLASE BLOOD LEVEL; ANAPHYLAXIS; ANEMIA; ARTHRALGIA; ARTICLE; CANCER GROWTH; CANCER RECURRENCE; CANCER STAGING; CEREBROVASCULAR ACCIDENT; CHILL; CHRONIC OBSTRUCTIVE LUNG DISEASE; COHORT ANALYSIS; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DYSPNEA; FAINTNESS; FALLING; FATIGUE; FEMALE; FEVER; FOLLOW UP; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HOT FLUSH; HUMAN; HYPERTENSION; HYPONATREMIA; HYPOTHYROIDISM; HYPOVOLEMIA; HYPOXIA; INFUSION RELATED REACTION; LUNG ABSCESS; MAJOR CLINICAL STUDY; MALE; MONOPLEGIA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; NAUSEA; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PROSPECTIVE STUDY; RADIATION PNEUMONIA; SIDE EFFECT; STOMATITIS; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; UNITED STATES; UROSEPSIS; VOMITING; ADVERSE EFFECTS; BLOOD; CARCINOMA, NON-SMALL-CELL LUNG; CHEMICALLY INDUCED; CLINICAL TRIAL; DISEASE COURSE; DRUG RESISTANCE; INTRAVENOUS DRUG ADMINISTRATION; LUNG NEOPLASMS; MIDDLE AGED; PATHOLOGY; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; RETREATMENT; SECONDARY; TUMOR RECURRENCE;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE PROGRESSION; DRUG RESISTANCE, NEOPLASM; DYSPNEA; FATIGUE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; LIPASE; LUNG NEOPLASMS; MALE; MIDDLE AGED; NAUSEA; NEOPLASM RECURRENCE, LOCAL; PLATINUM COMPOUNDS; PNEUMONIA; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; RETREATMENT;

EID: 85016412723     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(17)30240-1     Document Type: Article

References (33)

1. 1 Global Burden of Disease Cancer Collaboration, Fitzmaurice, C1, Dicker, D, Pain, A, et al. The global burden of cancer 2013. JAMA Oncol 1 (2015), 505–527.
2. 2 Dela Cruz, CS, Tanoue, LT, Matthay, RA, Lung cancer: epidemiology, etiology, and prevention. Clin Chest Med 32 (2011), 605–644.
3. 3 Schiller, JH, Harrington, D, Belani, CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346 (2002), 92–98.
4. 4 Fossella, F, Pereira, JR, von Pawel, J, et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 21 (2003), 3016–3024.
5. 5 Hanna, N, Shepherd, FA, Fossella, FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22 (2004), 1589–1597.
6. 6 Jackman, D, Pao, W, Riely, GJ, et al. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol 28 (2010), 357–360.
7. 7 Isozaki, H, Takigawa, N, Kiura, K, Mechanisms of acquired resistance to ALK inhibitors and the rationale for treating ALK-positive lung cancer. Cancers 7 (2015), 763–783.
8. 8 Dong, H, Strome, SE, Salomao, DR, et al. Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion. Nat Med 8 (2002), 793–800.
9. 9 Topalian, SL, Hodi, FS, Brahmer, JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 366 (2012), 2443–2454.
10. 10 Iwai, Y, Ishida, M, Tanaka, Y, Okazaki, T, Honjo, T, Minato, N, Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade. Proc Natl Acad Sci USA 99 (2002), 12293–12297.
11. 11 Hirano, F, Kaneko, K, Tamura, H, et al. Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity. Cancer Res 65 (2005), 1089–1096.
12. 12 Rizvi, NA, Hellmann, MD, Snyder, A, et al. Cancer immunology. mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science 348 (2015), 124–128.
13. 13 Borghaei, H, Paz-Ares, L, Horn, L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 373 (2015), 1627–1639.
14. 14 Brahmer, J, Reckamp, KL, Baas, P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 373 (2015), 123–135.
15. 15 Herbst, RS, Baas, P, Kim, DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 387 (2016), 1540–1550.
16. 16 Fehrenbacher, L, Spira, A, Ballinger, M, et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet 387 (2016), 1837–1846.
17. 17 Gettinger, SN, Horn, L, Gandhi, L, et al. Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol 33 (2015), 2004–2012.
18. 18 Antonia, S, Goldberg, SB, Balmanoukian, A, et al. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol 17 (2016), 299–308.
19. 19 Boyerinas, B, Jochems, C, Fantini, M, et al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res 3 (2015), 1148–1157.
20. 20 Fujii, R, Friedman, ER, Richards, J, et al. Enhanced killing of chordoma cells by antibody-dependent cell-mediated cytotoxicity employing the novel anti-PD-L1 antibody avelumab. Oncotarget 7 (2016), 33498–33511.
21. 21 Heery, CR, O'Sullivan-Coyne, G, Madan, RA, et al. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial Lancet Oncol. http://dx.doi.org/10.1016/S1470-2045(17)30239-5, 2017 published online March 31.
22. 22 Heery, CR, O'Sullivan Coyne, G, Marte, JL, et al. Pharmacokinetic profile and receptor occupancy of avelumab (MSB00110718C), an anti-PD-L1 monoclonal antibody, in a phase I, open-label, dose escalation trial in patients with advanced solid tumors. Proc Am Soc Clin Oncol, 33, 2015, 3055 abstr.
23. 23 Eisenhauer, EA, Therasse, P, Bogaerts, J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45 (2009), 228–247.
24. 24 Wolchok, JD, Hoos, A, O'Day, S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 15 (2009), 7412–7420.
25. 25 Garon, EB, Rizvi, NA, Hui, R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 372 (2015), 2018–2028.
26. 26 Rizvi, NA, Mazieres, J, Planchard, D, et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol 16 (2015), 257–265.
27. 27 Rizvi, NA, Brahmer, JR, Ou, S-I, et al. Safety and clinical activity of MEDI4736, an anti-programmed cell death-ligand (PD-L1) antibody, in patients with non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol, 33, 2015, 8032 abstr.
28. 28 Horn, L, Spigel, DR, Gettinger, SN, et al. Clinical activity, safety, and predictive biomarkers of the engineered antibody MPDL3280A (anti-PDL1) in non-small cell lung cancer (NSCLC): update from a phase Ia study. Proc Am Soc Clin Oncol, 33, 2015, 8029 abstr.
29. 29 Pilotto, S, Carbognin, L, Karachaliou, N, et al. Moving towards a customized approach for drug development: Lessons from clinical trials with immune checkpoint inhibitors in lung cancer. Transl Lung Cancer Res 4 (2015), 704–712.
30. 30 Herbst, RS, Soria, JC, Kowanetz, M, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515 (2014), 563–567.
31. 31 Hirsch, FR, Suda, K, Wiens, J, Bunn, PA Jr, New and emerging targeted treatments in advanced non-small-cell lung cancer. Lancet 388 (2016), 1012–1024.
32. 32 Scheel, AH, Dietel, M, Heukamp, LC, et al. Harmonized PD-L1 immunohistochemistry for pulmonary squamous-cell and adenocarcinomas. Mod Pathol 29 (2016), 1165–1172.
33. 33 Grenga, I, Donahue, RN, Lepone, LM, Richards, J, Schlom, J, A fully human IgG1 anti-PD-L1 MAb in an in vitro assay enhances antigen-specific T-cell responses. Clin Transl Immunology, 5, 2016, e83.