NCCN Non-Small Cell Lung Cancer V.1.2018 – Meeting – June 16, 2017

Guideline Page Panel Discussion/References Institution Vote and Request YES NO ABSTAIN ABSENT

NSCL-17 Based upon review of the data in the noted references, the panel 0 19 0 8 External request: Submission from consensus was to not add the following: Foundation Medicine, Inc. requesting: • Examples of broad molecular profiling • The addition of FoundationOne and • Alterations from NSCL-H to NSCL-17 FoundationOne CDx as example • Clarify broad molecular profiling is optimally completed as part “broad molecular profiles” of a single assay, in order to conserve tissue and to obtain as • The alterations currently listed in the much information as possible at the time of diagnosis. “Emerging Targeted Agents for Patients with Genetic Alterations” See Submission for References. on NSCL-H be moved to NSCL-17. These alterations include BRAF V600E, high-level MET amplification, MET exon 14 skipping mutations, RET rearrangements, and HER2 mutations. • Broad molecular profiling be clarified to specify that the profiling is optimally completed as part of a single assay, in order to conserve tissue and to obtain as much information as possible at the time of diagnosis. NSCL-24 Based upon review of the data in the noted reference, the panel 19 0 0 8 Internal request: consensus was to add ceritinib as an option for the first-line Institutional Review comment treatment of ROS 1 rearrangement positive metastatic NSCLC. This requesting the addition of ceritinib. is a category 2A recommendation.

External request: Submission from Lim SM, Kim HR, Lee J-S, et al. Open-label, multicenter, Phase II Novartis to consider the addition of study of ceritinib in patients with non–small cell lung cancer ceritinib as a treatment option in harboring ROS1 rearrangement. J Clin Oncol 2017;35(23):2613- patients who are ROS1 rearrangement 2618. positive. NCCN Non-Small Cell Lung Cancer V.1.2018 – Meeting – June 16, 2017

Guideline Page Panel Discussion/References Institution Vote and Request YES NO ABSTAIN ABSENT

NSCL-27 The panel consensus supported the continued listing of pemetrexed 12 1 6 8 Internal request: as an option for switch maintenance. This recommendation changed Institutional Review comment from a category 2B to a category 2A. requesting the reconsideration on the use of pemetrexed as switch maintenance. NSCL-27 Based upon review of the data in the noted references, the panel 0 15 3 9 External request: Submission from consensus was to not add durvalumab as an option for the treatment AstraZeneca to consider the addition of of metastatic NSCLC in patients who have progressed after one or durvalumab for the treatment of more systemic treatments. metastatic NSCLC in patients who have progressed after one or more systemic See Submission for References. treatments. NSCL-27 Based upon review of the data in the noted references, the panel 0 19 0 8 External request: Submission from consensus was to not add pembrolizumab as a systemic therapy Merck & Co, Inc. to consider the treatment option specifically for unresectable or metastatic addition of pembrolizumab as a microsatellite instability high (MSI-H) or deficient mismatch repair systemic therapy treatment option for (dMMR) solid tumors that have progressed following prior treatment unresectable or metastatic microsatellite and have no satisfactory alternative treatment options. instability high (MSI-H) or deficient mismatch repair (dMMR) solid tumors See Submission for References. that have progressed following prior treatment and have no satisfactory alternative treatment options. NCCN Non-Small Cell Lung Cancer V.1.2018 – Meeting – June 16, 2017

Guideline Page Panel Discussion/References Institution Vote and Request YES NO ABSTAIN ABSENT

NSCL-D Based upon review of the data in the noted references, the panel 15 2 2 8 Internal request: consensus was to add carboplatin/gemcitabine and Institutional Review comment carboplatin/pemetrexed as treatment options in neoadjuvant and requesting the addition of adjuvant therapy for patients with comorbidities or those unable to carboplatin/gemcitabine and tolerate cisplatin. This is a category 2A recommendation. carboplatin/pemetrexed as treatment options in neoadjuvant and adjuvant Usami N, Yokoi K, Hasegawa Y, et al. Phase II study of carboplatin therapy. and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: a report from the Central Japan Lung Study Group, CJLSG 0503 trial. Int J Clin Oncol 2010;15:583-587. Zhang L, Ou W, Liu Q, et al. Pemetrexed plus carboplatin as adjuvant chemotherapy in patients with curative resected non- squamous non-small cell lung cancer. Thorac Cancer 2014;5:50-56. NSCL-H Based upon review of the data in the noted references, the panel 0 19 0 8 External request: Submission from consensus was to not add the following genomic alterations in the Foundation Medicine, Inc. requesting “Emerging Targeted Agents for Patients with Genetic Alterations”: the following genomic alterations be high TMB, EGFR fusions, and NTRK fusions. listed in the “Emerging Targeted Agents for Patients with Genetic Alterations”: See Submission for References high TMB, EGFR fusions, and NTRK fusions. NSCL-H Based upon review of the data in the noted reference, the panel 13 1 5 8 Internal request: consensus was to add ado-trastuzumab emtansine for HER2 Institutional Review comment mutations. This is a category 2A recommendation. requesting the addition of ado- trastuzumab emtansine for HER2 Li BT, Shen R, Buonocore D, et al. Ado-trastuzumab emtansine in mutations. patients with HER2 mutant lung cancers: Results from a phase II basket trial. J Clin Oncol 2017;35:Abstract 8510. NSCL-H The panel consensus supported the removal of trastuzumab and 19 0 0 0 Internal request: afatinib as emerging targeted agents for HER2 mutations. Institutional Review comment requesting the removal of trastuzumab and afatinib for HER2 mutations.