Efficacy and Safety of Pembrolizumab in Patients Enrolled in KEYNOTE-030 in the United States: An Expanded Access Program

Journal of Immunotherapy

Volumn 40, Issue 9, 2017, Pages 334-340

  Gangadhar, Tara C ^a   Hwu, Wen Jen ^b   Postow, Michael A ^c,d   Hamid, Omid ^e   Daud, Adil ^f   Dronca, Roxana ^g   Joseph, Richard ^h   O'Day, Steven J ⁱ   Hodi, F S ^j   Pavlick, Anna C ^k   Kluger, Harriet ^l   Oxborough, Romina P ^m   Yang, Aiming ⁿ   Gazdoiu, Mihaela ^n,p   Kush, Debra A ⁿ   Ebbinghaus, Scot ⁿ   Salama, April K S ^o  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^c MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^d WEILL CORNELL MEDICAL COLLEGE   (United States)

^e Angeles Clinic and Research Institute   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g MAYO CLINIC   (United States)

^h MAYO CLINIC   (United States)

ⁱ JOHN WAYNE CANCER INSTITUTE   (United States)

^j DANA FARBER CANCER INSTITUTE   (United States)

^k NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^l YALE CANCER CENTER   (United States)

^m Clinigen Healthcare Limited   (United Kingdom)

ⁿ MERCK RESEARCH LABORATORIES   (United States)

^o DUKE CANCER INSTITUTE   (United States)

^p NOVARTIS PHARMA AG   (Switzerland)

more..

Author keywords

expanded access program; immunotherapy; melanoma; PD 1; pembrolizumab

Indexed keywords

B RAF KINASE; PEMBROLIZUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADVANCED CANCER; ARTICLE; CANCER IMMUNOTHERAPY; CHILD; CLINICAL ASSESSMENT; COMPASSIONATE USE; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; GOOD CLINICAL PRACTICE; HEALTH CARE QUALITY; HUMAN; INJECTION SITE REACTION; INOPERABLE CANCER; MAJOR CLINICAL STUDY; MALE; MELANOMA; NATIONAL HEALTH ORGANIZATION; PREGNANCY TEST; PRIORITY JOURNAL; PRURITUS; RASH; SCHOOL CHILD; SUBCUTANEOUS TISSUE; UNITED STATES; ADOLESCENT; ADULT; ADVERSE DRUG REACTION; AGED; CANCER STAGING; CLINICAL TRIAL; CLINICAL TRIAL (TOPIC); DRUG RESISTANCE; METASTASIS; MIDDLE AGED; PATHOLOGY; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DRUG RESISTANCE, NEOPLASM; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EXANTHEMA; FATIGUE; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM STAGING; TREATMENT OUTCOME; UNITED STATES; YOUNG ADULT;

EID: 85032871868     PISSN: 15249557     EISSN: 15374513     Source Type: Journal    
DOI: 10.1097/CJI.0000000000000186     Document Type: Article

References (34)

1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7-30.
2. Greenwald RJ, Freeman GJ, Sharpe AH. The B7 family revisited. Annu Rev Immunol. 2005;23:515-548.
3. Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol. 2008;8:467-477.
4. Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012;12:252-264.
5. Topalian SL, Drake CG, Pardoll DM. Immune checkpoint blockade: a common denominator approach to cancer therapy. Cancer Cell. 2015;27:450-461.
6. Leach DR, KrummelMF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science. 1996;271:1734-1736.
7. Topalian SL, Drake CG, Pardoll DM. Targeting the PD-1/ B7-H1(PD-L1) pathway to activate anti-tumor immunity. Curr Opin Immunol. 2012;24:207-212.
8. Schreiber RD, Old LJ, Smyth MJ. Cancer immunoediting: integrating immunity's roles in cancer suppression and promotion. Science. 2011;331:1565-1570.
9. Vesely MD, Kershaw MH, Schreiber RD, et al. Natural innate and adaptive immunity to cancer. Annu Rev Immunol. 2011;29: 235-271.
10. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711-723.
11. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364:2517-2526.
12. Hamid O, Robert C, Daud A, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med. 2013;369:134-144.
13. Ribas A, Hamid O, Daud A, et al. Association of pembrolizumab with tumor response and survival among patients with advanced melanoma. JAMA. 2016;315:1600-1609.
14. Robert C, Ribas A, Wolchok JD, et al. Anti-programmeddeath-receptor-1 treatment with pembrolizumab in ipilimumabrefractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet. 2014;384:1109-1117.
15. Robert C, Joshua AM,Weber JS, et al. Pembrolizumab (pembro; MK-3475) for advanced melanoma (MEL): randomized comparison of two dosing schedules. Ann Oncol. 2014;25:1-41.
16. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373:23-34.
17. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372:320-330.
18. Topalian SL, Sznol M, McDermott DF, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014;32:1020-1030.
19. Brahmer JR, Drake CG, Wollner I, et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010;28:3167-3175.
20. Ribas A, Puzanov I, Dummer R, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015;16:908-918.
21. Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372: 2521-2532.
22. Wolchok JD, Hoos A, O'Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immunerelated response criteria. Clin Cancer Res. 2009;15:7412-7420.
23. Tsai KK, Shoushtari AN, Munhoz RR, et al. Efficacy and safety of programmed death receptor-1 (PD-1) blockade in metastatic uveal melanoma (UM). J Clin Oncol. 2016;34 (suppl):9507.
24. Larkin J, D'Angelo S, Sosman JA, et al. Efficacy and safety of nivolumab (NIVO) monotherapyin the treatment of advanced mucosal melanoma (MEL). Pigment Cell Melanoma Res. 2015; 28:789.
25. Piperno-Neuman S, Servois V, Mariani P, et al. Activity of anti-PD1 drugs in uveal melanoma patients. J Clin Oncol. 2016;34 (suppl):9588.
26. Algazi AP, Tsai KK, Shoushtari AN, et al. Clinical outcomes in metastatic uveal melanoma treated with PD-1 and PD-L1 antibodies. Cancer. 2016;122:3344-3353.
27. Shoushtari AN, Munhoz RR, Kuk D, et al. The efficacy of anti-PD-1 agents in acral and mucosal melanoma. Cancer. 2016;122:3354-3362.
28. Hamid O, Ribas A, Hodi FS, et al. Efficacy of pembrolizumab in patients with advanced mucosal melanoma: data from KEYNOTE-001, 002, and 006. Pigment Cell Res. 2017;30:102.
29. Kottschade LA, McWilliams RR, Markovic SN, et al. The use of pembrolizumab for the treatment of metastatic uveal melanoma. Melanoma Res. 2016;26:300-303.
30. Ribas A, Li XN, Daud A, et al. Elevated baseline serum LDH does not preclude durable responses with pembrolizumab. Pigment Cell Res. 2017;30:136.
31. Blank C, Ribas A, Long GV, et al. Impact of baseline lactate dehyrodgenase concentration on efficacy in the KEYNOTE-006 study of pembrolizumab v ipilimumab. Pigment Cell Res. 2017;30:85.
32. Hodi FS, Hwu WJ, Kefford R, et al. Evaluation of immunerelated response criteria and RECIST v1.1 in patients with advanced melanoma treated with pembrolizumab. J Clin Oncol. 2016;34:1510-1517.
33. Robert C, Ribas A, Hamid O, et al. Three-year overall survival for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. J Clin Oncol. 2016;34(suppl):9503.
34. Robert C, Long GV, Schachter J, et al. Long-term outcomes in patients (pts) with ipilimumab (ipi)-naive advanced melanoma in the phase 3 KEYNOTE-006 study who completed pembrolizumab (pembro) treatment. J Clin Oncol. 2017;35(suppl): 9504.