Evolving Considerations in lmmuno-Oncology:

Bridging the Gaps Between Research and Clinical Care

A Global Educational Initiative for Healthcare Providers

Banner Image


I. Global Resources

Aide N, Hicks RJ, Le Tourneau C, et al. FDG PET/CT for assessing tumor response to immunotherapy : Report on the EANM symposium on immune modulation and recent review of the literature. Eur J Nucl Med Mol Imaging. 2019; 46:238-250. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30291373.

Arnaud-Coffin P, Maillet D, Gan HK, et al. A systematic review of adverse events in randomized trials assessing immune checkpoint inhibitors. Int J Cancer. January 17, 2019. DOI: 10.1002/ijc.32132. [Epub ahead of print]. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30653255.

Azvolinsky A. Researchers getting smarter about pairing cancer treatments. The Scientist. April 1, 2018. Available at: https://www.the-scientist.com/?articles.view/articleNo/52139/title/Researchers-Getting-Smarter-About-Pairing-Cancer-Treatments. Published April 1, 2018. Accessed December 11, 2018.

Bangalore Kumar A, Maus R, Markovic SN. Pharmacologic modulation of human immunity in the era of immuno-oncology: something old, something new. Mayo Clin Proc. 2018; 93:917-936. Available through PubMed:https://www.ncbi.nlm.nih.gov/pubmed/29887221.

Danilova L, Anagnostou V, Caushi JX. The Mutation-Associated Neoantigen Functional Expansion of Specific T Cells (MANAFEST) Assay: a sensitive platform for monitoring antitumor immunity. Cancer Immunol Res. 2018;6:888-899. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29895573.

El Chediak A, Shamseddine A, Bodgi L, et al. Optimizing tumor immune response through combination of radiation and immunotherapy. Med Oncol. 2017;34:165. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28828581.

Johnson DB, Chandra S, Sosman JA. Immune checkpoint inhibitor toxicity in 2018. JAMA. 2018;320:1702-1703. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30286224.

Kamta J, Chaar M, Ande A, et al. Advancing cancer therapy with present and emerging immuno-oncology approaches. Front Oncol. 2017;7:64. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28459041.

Pons-Tostivint E, Latouche A, Vaflard P, et al. Comparative analysis of durable responders on immune checkpoint inhibitors (ICI) versus other systemic therapies: A meta-analysis of phase III trials. J Clin Oncol. 2018;(suppl)36: 3070. Available at: https://meetinglibrary.asco.org/record/159245/abstract. Accessed January 24, 2019.

Samstein RM, Lee CH, Shoushtari AN, et al. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. Published January 14, 2019; DOI: 10.1038/s41588-018-0312-8. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30643254/.

Sasidharan Nair V, Elkord E. Immune checkpoint inhibitors in cancer therapy: a focus on T-regulatory cells. Immunol Cell Biol. 2018; 96:21-33. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29359507.

Steuer CE, Ramalingam SS. Tumor mutation burden: leading immunotherapy to the era of precision medicine? J Clin Oncol. 2018;36:631-632. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29337637.

Wang DY, Salem JE, Cohen JV, et al. Fatal toxic effects associated with immune checkpoint inhibitors: a systematic review and meta-analysis. JAMA Oncol. 2018;4:1721-1728. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30242316.

Yang Q, Xu Z, Zheng L, Zhang L, et al. Multimodal detection of PD-L1: reasonable biomarkers for immune checkpoint inhibitor. Am J Cancer Res. 2018;8:1689-1696. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30323963.

Zhao X, Subramanian S. Oncogenic pathways that affect antitumor immune response and immune checkpoint blockade therapy. Pharmacol Ther. 2018;181:76-84. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28720430.

By Cancer Type

Bladder Cancer

Ghatalia P, Zibelman M, Geynisman DM, et al. Approved checkpoint inhibitors in bladder cancer: which drug should be used when? Ther Adv Med Oncol. July 30, 2018;1758835918788310. DOI: 10.1177/1758835918788310. eCollection 2018. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6066800/.

Soria F, Beleni AI, D'Andrea D, et al. Pseudoprogression and hyperprogression during immune checkpoint inhibitor therapy for urothelial and kidney cancer. World J Urol. 2018;36:1703-1709. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29549485.

Preliminary data for NKTR-214 in combination with nivolumab for patients with stage IV metastatic melanoma, renal cell carcinoma, and urothelial cancers presented at ASCO 2018 [press release]. Chicago, Illinois: Nektar Therapeutics; June 2, 2018. Available at: http://ir.nektar.com/news-releases/news-release-details/preliminary-data-nktr-214-combination-opdivo-nivolumab-patients. Accessed February 27, 2019.

Gastric Cancer

Coutzac C, Pernot S, Chaput N, et al. Immunotherapy in advanced gastric cancer, is it the future? Crit Rev Oncol Hematol. 2019; 133:25-32. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30661655.

Taieb J, Moehler M, Boku N, et al. Evolution of checkpoint inhibitors for the treatment of metastatic gastric cancers: Current status and future perspectives. Cancer Treat Rev. 2018;66:104-113. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29730461.

Togasaki K, Sukawa Y, Kanai T, et al. Clinical efficacy of immune checkpoint inhibitors in the treatment of unresectable advanced or recurrent gastric cancer: an evidence-based review of therapies. Onco Targets Ther. 2018;11:8239-8250. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30538493.

Head and Neck Squamous Cell Carcinoma (HNSCC)

Burtness B, Harrington KJ, Greil R, et al. KEYNOTE-048: Phase III study of first-line pembrolizumab (P) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Annals Oncol. 2018;29(suppl 8):VIII729; Abstract LBA8_PR. Available at: https://doi.org/10.1093/annonc/mdy424.045. Accessed October 29, 2018.

Cohen EEW, Mehra R, et al. ECHO-310: A phase III, randomized trial of epacadostat + nivolumab + chemo vs EXTREME as first-line treatment of recurrent/metastatic SCCHN. J Clin Oncol. 2018;(suppl)36: Abstract TPS6092. Available at: https://meetinglibrary.asco.org/record/165278/abstract. Accessed February 27, 2019.

Helwick, C. Pembrolizumab plus chemoradiotherapy in HPV-positive head and neck cancer. The ASCO Post Web site. Available at: http://www.ascopost.com/issues/december-25-2018/pembrolizumab-plus-chemoradiotherapy-in-hpv-positive-head-and-neck-cancer/. Published December 25, 2018. Accessed February 5, 2019.

Welch A. Expert highlights avelumab trial and future of immunotherapy in head and neck cancer. OncLive Web site. Available at: https://www.onclive.com/web-exclusives/expert-highlights-avelumab-trial-and-future-of-immunotherapy-in-head-and-neck-cancer. Published August 8, 2017. Accessed December 11, 2018.

Melanoma

Helwick C. Optimal duration of checkpoint inhibition in melanoma is no more than 2 years. The ASCO Post Web site. Available at: http://www.ascopost.com/issues/december-25-2018/optimal-duration-of-checkpoint-inhibition-in-melanoma-is-no-more-than-2-years/. Published December 25, 2018. Accessed February 5, 2019.

Inacio P. Yervoy, Local injection of candidate therapy tilsotolimod shrink advanced melanoma tumors, trial shows. Immuno-Oncology News Web site. Available at: https://immuno-oncologynews.com/2018/12/04/yervoy-local-tumor-injection-tilsotolimod-shrink-tumors-advanced-melanoma/. Published December 4, 2018. Accessed February 27, 2019.

Marques Lopes J. Tavo reverses resistance to PD-1 inhibitors in metastatic melanoma, phase 2b trial suggests. Immuno-Oncology News Web site. Available at: https://immuno-oncologynews.com/2018/11/30/tavo-reverses-resistance-pd-1-inhibitors-metastatic-melanoma-phase-2b-trial/. Published November 30, 2018. Accessed December 13, 2018.

First data for NKTR-214 in combination with nivolumab for patients with stage IV melanoma, renal cell carcinoma and non-small cell lung cancers, including patients with PD-L1 negative status, revealed at SITC 2017 [press release]. National Harbor, Maryland: Nektar Therapeutics; November 11, 2017. Available at: http://ir.nektar.com/news-releases/news-release-details/first-data-nktr-214-combination-opdivor-nivolumab-patients-stage. Accessed October 25, 2018.

Preliminary data for NKTR-214 in combination with nivolumab for patients with stage IV metastatic melanoma, renal cell carcinoma, and urothelial cancers presented at ASCO 2018 [press release]. Chicago, Illinois: Nektar Therapeutics; June 2, 2018. Available at: http://ir.nektar.com/news-releases/news-release-details/preliminary-data-nktr-214-combination-opdivo-nivolumab-patients. Accessed February 27, 2019.

Merkel Carcinoma (MCC)

Martins I. Keytruda better than chemotherapy for untreated advanced merkel cell carcinomas, Phase II trial suggests. Immuno-Oncology News Web site. Available at: https://immuno-oncologynews.com/2019/02/22/keytruda-better-than-chemotherapy-untreated-advanced-merkel-cell/. Published February 22, 2019. Accessed February 27, 2019.

NSCLC

Barber J. Roche's atezolizumab plus chemotherapy cut risk of lung cancer progression by 40 percent, but falls short of Merck & Co.'s pembrolizumab. FirstWord Pharma Web site. Available at: https://www.firstwordpharma.com/node/1592814. Published September 24, 2018. Accessed February 27, 2019.

Barnet MB, Cooper WA, Boyer MJ, et al. Immunotherapy in non-small cell lung cancer: shifting prognostic paradigms. J Clin Med. 2018;7:151. DOI: 10.3390/jcm7060151. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29904031.

Dennis M. AstraZeneca's Imfinzi reduces risk of death by almost one third in lung cancer trial. FirstWord Pharma Web site. Available at: https://www.firstwordpharma.com/node/1593067. Published September 25, 2018. Accessed February 27, 2019.

Dennis M. Detailed results from AstraZeneca's MYSTIC study suggest survival benefit of durvalumab, tremelimumab combination in patients with high TMB. FirstWord Pharma Web site. Available at: https://www.firstwordpharma.com/node/1611575. Published December 14, 2018. Accessed February 27, 2019.

Melao A. Entinostat-pembrolizumab combo shows promise in certain NSCLC patients who received prior immune checkpoint therapies. Immuno-Oncology News Web site. Available at: https://immuno-oncologynews.com/2018/10/17/entinostat-keytruda-combo-promotes-positive-response-in-advanced-nsclc-patients/. Published October 17, 2018. Accessed October 29, 2018.

Moya-Horno I, Viteri S, Karachaliou N, et al. Combination of immunotherapy with targeted therapies in advanced non-small cell lung cancer. Ther Adv Med Oncol. 2018;10:1-12. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29383034.

Shaw AT, Lee S-H, Ramalingam, SS, et al. Avelumab (anti–PD-L1) in combination with crizotinib or lorlatinib in patients with previously treated advanced NSCLC: Phase Ib results from JAVELIN Lung 101. J Clin Oncol. 2018;(suppl)36. Abstract 9008 Available at: https://meetinglibrary.asco.org/record/160339/abstract. Accessed January 24, 2019.

Stenger M. Durvalumab improves overall survival after chemoradiotherapy in unresectable, stage III NSCLC. The ASCO Post Web site. Available at: http://www.ascopost.com/issues/december-25-2018/durvalumab-in-unresectable-stage-iii-nsclc/. Published December 25, 2018. Accessed March 5, 2019.

First data for NKTR-214 in combination with nivolumab for patients with stage IV melanoma, renal cell carcinoma and non-small cell lung cancers, including patients with PD-L1 negative status, revealed at SITC 2017 [press release]. National Harbor, MD: Nektar Therapeutics; November 11, 2017. Available at: http://ir.nektar.com/news-releases/news-release-details/first-data-nktr-214-combination-opdivor-nivolumab-patients-stage. Accessed October 25, 2018.

Ovarian Cancer

Rodriguez Freixinos V, Garcia A, Fasani R, et al. Immune profile and outcomes of patients with gynecological malignancies enrolled in early phases immunotherapy trials. J Clin Oncol. 2018;(suppl)36: Abstract 5595. Available at: https://meetinglibrary.asco.org/record/163425/abstract. Accessed January 24, 2019.

Urciuoli B. Ovarian cancer research pivots toward combination therapies. Oncology Nursing News Web site. Available at: http://www.oncnursingnews.com/web-exclusives/ovarian-cancer-research-turns-to-combination-immunotherapy. Published January 30, 2018.

The ASCO Post. Addition of a CTLA-4–targeted therapy to a checkpoint inhibitor in ovarian cancer. The ASCO Post Web site. Available at: http://www.ascopost.com/News/59329. Published October 3, 2018. Accessed January 22, 2019.

Renal Cell Carcinoma (RCC)

Barber J. Merck & Co. says pembrolizumab in combination with Pfizer's axitinib significantly improves OS, PFS in renal cancer study. FirstWord Pharma Web site. Available at: https://www.firstwordpharma.com/node/1598239. Published October 18, 2018. Accessed October 19, 2018.

Cella D, Granwald V, Escudier B, et al. Quality of life in patients with advanced renal cell carcinoma in the randomized, open-label CheckMate 214 trial. J Clin Oncol. 2018;(suppl)36: Abstract 3073. Available at: https://meetinglibrary.asco.org/record/159249/abstract. Accessed January 24, 2019.

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 Ib trial.. Lancet Oncol. 2018;19:451-460. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29530667.

Columbus G. Avelumab/axitinib nearly doubles PFS, ORR in frontline RCC. OncLive Web site. Available at: https://www.onclive.com/conference-coverage/esmo-2018/avelumabaxitinib-nearly-doubles-pfs-orr-in-frontline-rcc. October 21, 2018. Accessed January 22, 2019.

Martins I. FDA grants priority review to pembrolizumab-axitinib combo for untreated, advanced kidney cancer patients. Immuno-Oncology News Web site. Available at: https://immuno-oncologynews.com/2019/02/20/keytruda-inlyta-combo-granted-fda-priority-review. Published February 20, 2019. Accessed February 26, 2019.

Martins I. Nivolumab-ipilimumab combo delays need for additional treatment in renal cell carcinoma patients, phase 3 data shows. Immuno-Oncology News Web site. Available at: https://immuno-oncologynews.com/2018/11/27/opdivo-yervoy-combo-benefits-renal-cell-carcinoma-patients-phase-3-trial/. Published November 27, 2018. Accessed December 14, 2018.

Mountfort K. Eisai and Merck announce latest data on lenvatinib and pembrolizumab for multiple cancer types at ASCO 2018. Touch Oncology Web site. Available at: https://www.touchoncology.com/content/eisai-and-merck-announce-latest-data-lenvatinib-and-pembrolizumab-multiple-cancer-types-asco. Accessed January 22, 2019.

Soria F, Beleni AI, D’Andrea D et al. Pseudoprogression and hyperprogression during immune checkpoint inhibitor therapy for urothelial and kidney cancer. World J Urol. 2018;36:1703-1709. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29549485.

First data for NKTR-214 in combination with nivolumab for patients with stage IV melanoma, renal cell carcinoma and non-small cell lung cancers, including patients with PD-L1 negative status, revealed at SITC 2017 [press release]. National Harbor, Maryland: Nektar Therapeutics; November 11, 2017. Available at: http://ir.nektar.com/news-releases/news-release-details/first-data-nktr-214-combination-opdivor-nivolumab-patients-stage. Accessed October 25, 2018.

Preliminary data for NKTR-214 in combination with nivolumab for patients with stage IV metastatic melanoma, renal cell carcinoma, and urothelial cancers presented at ASCO 2018 [press release]. Chicago, Illinois: Nektar Therapeutics; June 2, 2018. Available at: http://ir.nektar.com/news-releases/news-release-details/preliminary-data-nktr-214-combination-opdivo-nivolumab-patients. Accessed February 27, 2019.



II. Region Specific Resources

General

Domingues Pires Da Silva IE, Lo S, Gonzalez M, et al. Distinct patterns of response and toxicity by sites of metastases in patients treated with ipilimumab combined with PD-1 antibodies. J Clin Oncol. 2018;36(suppl): Abstract 9553. Available at: https://meetinglibrary.asco.org/record/163576/abstract. Accessed January 24, 2019.

Mitchell EL, Lau PKH, Khoo C, et al. Rheumatic immune-related adverse events secondary to anti-programmed death-1 antibodies and preliminary analysis on the impact of corticosteroids on antitumor response: A case series. Eur J Cancer. 2018; 105:88-102. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30439628.

Tiu C, Wong A, Herschtal A, et al. Outcomes of Australian patients receiving nonfunded anti-PD-1 immune checkpoint inhibitors for nonmelanoma cancers. Asia Pac J Clin Oncol. 2018; March 1. DOI: 10.1111/ajco.12867. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29498208.

By Cancer Type

Bladder Cancer

Australian Government Department of Health, Therapeutic Goods Administration. Drug class and therapeutic indication (metastatic urothelial carcinoma). In: Australian Public Assessment Report for Nivolumab. Symonston, Australia: Therapeutic Goods Administration; 2018: 6. Available at: https://www.tga.gov.au/sites/default/files/auspar-nivolumab-180806.pdf. Published August 6, 2018. Accessed January 24, 2019.

Head and Neck Squamous Cell Carcinoma (HNSCC)

Australian Government Department of Health, Therapeutic Goods Administration. Drug class and therapeutic indication (squamous cell cancer of the head and neck). In: Australian Public Assessment Report for Nivolumab. Symonston, Australia: Therapeutic Goods Administration; 2018: 6. Available at: https://www.tga.gov.au/sites/default/files/auspar-nivolumab-180806.pdf. Published August 6, 2018. Accessed January 24, 2019.

Melanoma

Gonzalez M, Menzies AM, Saw R, et al. Determining optimal sequencing of anti-PD-1 and BRAF-targeted therapy: A phase II randomized study of neoadjuvant pembrolizumab with/without dabrafenib and trametinib in BRAF V600 mutant resectable stage IIIb/c/d melanoma (NeoTrio trial). J Clin Oncol. 2018;36 (suppl): Abstract TPS9604. Available at: https://meetinglibrary.asco.org/record/165458/abstract. Accessed February 27, 2019.

Lacey J, Lomax AJ, McNeil C, et al. A supportive care intervention for people with metastatic melanoma being treated with immunotherapy: A pilot study assessing feasibility, perceived benefit, and acceptability. Support Care Cancer. 2019;27:1497-1507. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30392112.

Parakh S, Randhawa M, Nguyen B, et al. Real-world efficacy and toxicity of combined nivolumab and ipilimumab in patients with metastatic melanoma. Asia Pac J Clin Oncol. 2019; 15:26-30. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30426665.

Australian Government Department of Health, Therapeutic Goods Administration. Drug class and therapeutic indication ([Stage III] or metastatic [Stage IV] melanoma). In: Australian Public Assessment Report for Nivolumab. Symonston, Australia: Therapeutic Goods Administration; 2018:6. Available at: https://www.tga.gov.au/sites/default/files/auspar-nivolumab-180806.pdf. Published August 6, 2018. Accessed January 24, 2019.

Australian Government Department of Health, Therapeutic Goods Administration. Drug class and therapeutic indication (metastatic [Stage IV] melanoma with M1c disease or elevated lactic dehydrogenase [LDH]). In: Australian Public Assessment Report for Nivolumab. Symonston, Australia: Therapeutic Goods Administration; 2018:6. Available at: https://www.tga.gov.au/sites/default/files/auspar-nivolumab-180806.pdf. Published August 6, 2018. Accessed January 24, 2019.

Merkel Cell Carcinoma

Avelumab for Merkel cell carcinoma. Aust Prescr. 2018;41:55. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895477/. Accessed February 27, 2019.

NSCLC

Moor RJ, Roberts KE, Mason R, et al. Immune-related adverse events and nivolumab outcomes in non-small cell lung cancer patients: A multi-institutional, retrospective cohort study. J Clin Oncol. 2018;36(suppl): Abstract 9067. Available at: https://meetinglibrary.asco.org/record/161056/abstract. Accessed February 27, 2019.

Ye L, Leslie C, Jacques A, et al. Programmed death ligand-1 expression in non-small cell lung cancer in a Western Australian population and correlation with clinicopathologic features. Mod Pathol. Published November 6, 2018. DOI: 10.1038/s41379-018-0173-9. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30401947.

Australian Government Department of Health, Therapeutic Goods Administration. Drug class and therapeutic indication (for locally advanced or metastatic squamous non-small cell lung cancer [NSCLC] with progression on or after prior chemotherapy). In: Australian Public Assessment Report for Nivolumab. Symonston, Australia: Therapeutic Goods Administration; 2018:6. Available at: https://www.tga.gov.au/sites/default/files/auspar-nivolumab-180806.pdf. Published August 6, 2018. Accessed January 24, 2019.

Scully RP. New treatment for lung cancer approved: The TGA has approved pembrolizumab (Keytruda, MSD), a chemotherapy-free treatment, for metastatic first-line and advanced second-line non-small-cell lung cancer. Medical Republic Web site. Available at: http://medicalrepublic.com.au/new-first-line-treatment-lung-cancer-approved/7868. Published March 14, 2017. Accessed January 22, 2019.

Renal Cell Carcinoma (RCC)

Australian Government Department of Health, Therapeutic Goods Administration. Drug class and therapeutic indication (advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy in adults). In: Australian Public Assessment Report for Nivolumab. Symonston, Australia: Therapeutic Goods Administration; 2018:6. Available at: https://www.tga.gov.au/sites/default/files/auspar-nivolumab-180806.pdf. Published August 6, 2018. Accessed January 24, 2019.

Bladder Cancer

Bensch F, van der Veen EL, Lub-de Hooge MN, et al. 89Zr-atezolizumab imaging as a noninvasive approach to assess clinical response to PD-L1 blockade in cancer. Nat Med. 2018;24:1852-1858. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30478423.

Melanoma

Dupuis F, Lamant L, Gerard E, et al. Clinical, histological and molecular predictors of metastatic melanoma responses to anti-PD-1 immunotherapy. Br J Cancer. 2018;119:193-199. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29973670.

Moya-Plana A, Herrera-Gómez RG, Rossoni C, et al. Response assessment to anti-CTLA4 or/and anti-PD1 immunotherapy in mucosal melanomas. J Clin Oncol. 2018;36(suppl) :Abstract e21517. Available at: https://meetinglibrary.asco.org/record/163575/abstract. Accessed January 24, 2019.

Merkel Cell Carcinoma

European Commission approves avelumab for metastatic merkel cell carcinoma [press release]. New York: PRNewswire; September 21, 2017. Available at: https://www.prnewswire.com/news-releases/european-commission-approves-bavencio-avelumab-for-metastatic-merkel-cell-carcinoma-646337323.html. Accessed November 26, 2018.

NSCLC

Bensch F, van der Veen EL, Lub-de Hooge MN, et al. 89Zr-atezolizumab imaging as a noninvasive approach to assess clinical response to PD-L1 blockade in cancer. Nat Med. 2018;24:1852-1858. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30478423.

Inacio P. European panel favors approval of pembrolizumab-chemo combo as first-line therapy for NSCLC. Immuno-Oncology News Web site. Available at: https://immuno-oncologynews.com/2019/02/19/european-panel-favors-keytruda-chemo-combo-therapy-nsclc/. Published February 19, 2019. Accessed February 26, 2019.

Mazieres J, Drilon AE, Mhanna L, et al. Efficacy of immune-checkpoint inhibitors in nonsmall cell lung cancer patients harboring activating molecular alterations (ImmunoTarget). J Clin Oncol. 2018;36(suppl): Abstract 9010. Available at: https://meetinglibrary.asco.org/record/160336/abstract. Accessed February 27, 2019.

European commission approves Merck’s pembrolizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations [press release]. Kenilworth, NJ: Business Wire; September 10, 2018. Available at: https://www.businesswire.com/news/home/20180910005402/en/European-Commission-Approves-Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-Combination. Accessed October 30, 2018.

Renal Cell Carcinoma (RCC)

Bristol-Myers Squibb announces European commission approval for nivolumab plus low-dose ipilimumab. StreetInsider Web site. January 14, 2019. Available at: https://www.streetinsider.com/Corporate+News/Bristol-Myers+Squibb+%28BMY%29+Announces+European+Commission+Approval+for+Opdivo+%28nivolumab%29+Plus+Low-Dose+Yervoy+%28ipilimumab%29/15004986.html. Accessed February 27, 2019.

General

Merck’s pembrolizumab receives five new approvals in Japan, including in advanced non-small cell lung cancer NSCLC, as adjuvant therapy for melanoma, and in advanced microsatellite instability-high (MSI-H) tumors [press release]. Kenilworth, NJ: Business Wire. January 3, 2019. Available at: https://www.mrknewsroom.com/news-release/oncology/mercks-keytruda-pembrolizumab-receives-five-new-approvals-japan-including-adva. Accessed January 4, 2019.

By Cancer Type

Bladder Cancer

Merck’s pembrolizumab approved in Japan for use in the treatment of patients with urothelial carcinoma that is unresectable with radical surgery who have progressed following cancer chemotherapy. first anti-PD-1 therapy approved in Japan for previously-treated urothelial carcinoma, a type of bladder cancer [press release]. Kenilworth, NJ: Business Wire. January 2, 2018. Available at: https://www.businesswire.com/news/home/20180102005293/en/Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-Approved-Japan-Treatment-Patients. Accessed November 15, 2018.

Gastric Cancer

Nishina T, Hironaka S, Kadowaki S, et al. An investigator initiated multicenter phase I/II study of paclitaxel, ramucirumab with nivolumab as the second-line treatment in patients with metastatic gastric cancer. J Clin Oncol. 2018;36(suppl): Abstract TPS4131. Available at: https://meetinglibrary.asco.org/record/165339/abstract. Accessed February 27, 2019.

Nivolumab Approved in Japan for Unresectable Advanced or Recurrent Gastric Cancer that Has Progressed after Chemotherapy. The ASCO Post Web site. Available at: http://www.ascopost.com/News/58104. Published October 3, 2017. Accessed January 22, 2019.

Melanoma

Yamazaki N, Kiyohara Y, Uhara H, et al. Efficacy and safety of nivolumab in Japanese patients with previously untreated advanced melanoma: A phase II study. Cancer Sci. 2017;108:1223-1230. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28342215.

Merck’s pembrolizumab receives five new approvals in Japan, including in advanced non-small cell lung cancer NSCLC, as adjuvant therapy for melanoma, and in advanced microsatellite instability-high (MSI-H) tumors [press release]. Kenilworth, NJ: Business Wire. January 3, 2019. Available at: https://www.mrknewsroom.com/news-release/oncology/mercks-keytruda-pembrolizumab-receives-five-new-approvals-japan-including-adva. Accessed January 4, 2019.

Merkel Cell Carcinoma

Avelumab approved for merkel cell carcinoma in Japan [press release]. New York: PR Newswire; September 27, 2017. Available at: https://www.prnewswire.com/news-releases/bavencio-avelumab-approved-for-merkel-cell-carcinoma-in-japan-648151903.html. Accessed May 22, 2018

NSCLC

Nishio M, Takahashi T, Yoshioka H, et al. KEYNOTE-025: Phase Ib study of pembrolizumab in Japanese patients with previously treated PD-L1-positive advanced NSCLC. Cancer Sci. January 7, 2019. DOI: 10.1111/cas.13932. Available through PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30618179.

Yoh K, Matsumoto S, Nishino K, et al. Immuno-oncology biomarker study in a large cohort of LC-SCRUM-Japan: Assessment of PD-L1 expression and tumor mutation burden in non-small cell lung cancer patients treated with immune checkpoint inhibitors. J Clin Oncol. 2018;36 (suppl): Abstract 9070. Available at: https://meetinglibrary.asco.org/record/160822/abstract. Accessed January 24, 2019.

Yonesaka K, Kudo K, Takamura S, et al. Relationship between checkpoint molecule B7-H3 and refractoriness to anti-PD-1 therapy in non-small cell lung cancer. J Clin Oncol. 2018;36 (suppl): Abstract 3023. Available at: https://meetinglibrary.asco.org/record/159248/abstract. Accessed January 24, 2019.

Merck’s pembrolizumab receives five new approvals in Japan, including in advanced non-small cell lung cancer NSCLC, as adjuvant therapy for melanoma, and in advanced microsatellite instability-high (MSI-H) tumors [press release]. Kenilworth, NJ: Business Wire. January 3, 2019. Available at: https://www.mrknewsroom.com/news-release/oncology/mercks-keytruda-pembrolizumab-receives-five-new-approvals-japan-including-adva. Accessed January 4, 2019.

General

FDA approves first cancer treatment for any solid tumor with a specific genetic feature [press release]. Silver Spring, Maryland: US Food and Drug Administration; May 23, 2017. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm560167.htm. Accessed September 21, 2017.

By Cancer Type

Bladder Cancer

Broderick JM. FDA approves durvalumab for bladder cancer. OncLive Web site. Available at: https://www.onclive.com/web-exclusives/fda-approves-durvalumab-for-bladder-cancer. Published May 1, 2107. Accessed January 24, 2019.

Nivolumab for treatment of urothelial carcinoma [press release]. Silver Spring, Maryland: US Food and Drug Administration; February 2, 2017. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm. Accessed January 24, 2019.

Cutaneous Squamous Cell Carcinoma (CSCC)

FDA approves first treatment for advanced form of the second most common skin cancer: New drug targets PD-1 pathway [press release]. Silver Spring, Maryland: US Food and Drug Administration; September 28, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622044.htm. Accessed October 23, 2018.

Melanoma

Martins I. FDA approves pembrolizumab for melanoma patients after tumor resection. February 27, 2019. Immuno-Oncology News Web site. Available at: https://immuno-oncologynews.com/2019/02/27/fda-approves-keytruda-for-melanoma-patients-after-tumor-resection/. Published February 27, 2019. Accessed March 5, 2019.

Merkel Cell Carcinoma (MCC)

Health Canada approves avelumab for injection for the treatment of metastatic Merkel cell carcinoma in previously treated adult patients. Cision Web site. Available at: https://www.newswire.ca/news-releases/health-canada-approves-bavencio-avelumab-for-injection-for-the-treatment-of-metastatic-merkel-cell-carcinoma-mcc-in-previously-treated-adult-patients-674850103.html. Published February 22, 2018. Accessed November 26, 2018.

US FDA approves pembrolizumab for Merkel cell carcinoma [press release]. Silver Spring, Maryland: US Food and Drug Administration; December 19, 2018. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628867.htm. Accessed December 21, 2018.

Approved drugs: avelumab (Bavencio). FDA.gov Web site. Updated May 30, 2017. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm547965.htm. Accessed February 27, 2019.

NSCLC

Broderick JM. FDA approves frontline pembrolizumab regimen for squamous NSCLC; regardless of PD-L1 expression. OncLive Web site. Available at: https://www.onclive.com/web-exclusives/fda-approves-frontline-pembrolizumab-regimen-for-squamous-nsclc. Published October 30, 2018. Accessed October 31, 2018.

FDA expands approval of durvalumab to reduce the risk of NSCLC progression. ASCO Post Web site. Available at: http://ascopost.com/News/58550. Published February 20, 2018. Accessed January 24, 2019.

FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC. FDA.gov Web site. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617471.htm. Published August 20, 2018. Accessed October 30, 2018.

Renal Cell Carcinoma (RCC)

Approved drugs: FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma. FDA.gov Web site. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm. Published April 16, 2018. Accessed December 11, 2018.