NCCN Non Small Cell Lung Cancer V Meeting July 8, 2016

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1 NSCL 3 Submission from Myriad requesting the following statement to be listed as an additional high risk factor in footnote p : For lung ADC, a highrisk 46 gene molecular prognostic score determined by a CLIA certified RNA expression based assay. NSCL 17 Submission from Genentech requesting the review of the updated labeling information regarding blood based epidermal growth factor receptor (EGFR) mutation testing as an option for patients with challenges related to tissue biopsy. The data are not validated in prospective trials and add limited information to the wellestablished clinical and pathological parameters used to evaluate patients with lung cancer. submission, the panel consensus was to add the following footnote, If repeat biopsy is not feasible, plasma biopsy should be considered. NSCL 17 (Evidence Block version) Submission from Boehringer Ingelheim requesting a review of the efficacy ratings for tyrosine kinase inhibitors (TKls} for the first line treatment of patients with epidermal growth factor receptor (EGFR} sensitizing mutations. The Panel consensus was to note a similar efficacy rating (5) for erlotinib, afatinib, and gefitinib.

2 NSCL 19 Submission from AstraZeneca requesting EGFRm NSCLC in treatmentnaïve patients. EGFRm NSCLC in patients who are T790M negative who have progressed on a prior EGFR TKI. EGFRm NSCLC in patients who are T790M unknown who have progressed on a prior EGFR TKI. NSCL 19 Submission from AstraZeneca requesting EGFRm NSCLC in patients who have brain metastasis or leptomeningeal disease. submission, the panel consensus was to add osimertinib (category 2A) as an option in subsequent therapy for patients with symptomatic, brain progression and EGFR T790M mutation positive tumors.

3 NSCL 19 Institutional review comment suggesting the addition of T790M testing into the algorithm and adding the option of a plasma biopsy. Submission from AstraZeneca Request placement of T790M mutation testing in treatment algorithm. submission, the panel consensus was to add T790M testing into the algorithm. The following footnote added: If tissue biopsy not feasible, plasma biopsy should be considered. NSCL 20 Submission from Genentech requesting the review of the available data on the use of alectinib in ALK inhibitor naïve patients with ALK+ NSCLC. NSCL 20 Submission from Novartis requesting the addition of ceritinib as a treatment option in patients with metastatic NSCLC who have not received prior ALK inhibitor therapy.

4 NSCL 23 the addition of pembrolizumab as a first line treatment option for patients with PD L1 expression 50% and tumors that are EGFR/ALK/ROS1 negative. Submission from Merck and Co. requesting to consider inclusion of pembrolizumab as initial therapy for previously untreated, metastatic non small cell lung cancer (NSCLC) patients whose tumors express PD L1 on >50% of tumor cells and lack epidermal growth factor receptor sensitizing mutations or anaplastic lymphoma kinase translocations. Based upon review of the data in the noted reference, the panel consensus was to add pembrolizumab as a first line therapy option for patients with PD L1 expression 50% and tumors that are EGFR/ALK/ROS1 negative. vote on October 13, 2016, supported pembrolizumab as a category 1 recommendation. Reck M, Rodríguez Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD L1 positive non small cell lung cancer. N Engl J Med 2016; October 9 Epub NSCL 24/NSCL 25 Submission from Genentech requesting the review of the available data on the use of atezolizumab in NSCLC. NSCL 24/NSCL 25 Submission from Bristol Myers Squibb requesting the review of a phase 1 study evaluating the use of nivolumab monotherapy as first line treatment of patients with advanced NSCLC.

5 NSCL 24/NSCL 25 Submission from Bristol Myers Squibb requesting the review of a phase 1 study evaluating the use of nivolumab plus ipilimumab as first line treatment of patients with advanced NSCLC.1 NSCL A 3 of 5 Submission from Boehringer Ingelheim requesting inclusion of language that would provide clear expectation regarding minimizing the time from biopsy/tissue procurement to result availability. Minimizing this time will address a significant gap in care in terms of accurate diagnosis and appropriate use of targeted therapies. NSCL E the removal of the regimen: Cisplatin 50 mg/m 2 on days 1, 8, 29, and 36; etoposide 50 mg/m 2 days 1 5, 29 33; concurrent thoracic RT followed by cisplatin 50 mg/m 2 and etoposide 50 mg/m 2 x 2 additional cycles (category 2B). The panel consensus was to remove the regimen, Cisplatin 50 mg/m 2 on days 1, 8, 29, and 36; etoposide 50 mg/m 2 days 1 5, 29 33; concurrent thoracic RT followed by cisplatin 50 mg/m 2 and etoposide 50 mg/m 2 x 2 additional cycles, as an adjuvant or definitive concurrent chemotherapy/rt option. This regimen was removed based on the Phase 3 randomized trial showing better outcomes with cisplatin/pemetrexed. Senan S, Brade A, Wang LH, et al. PROCLAIM: randomized phase III trial of pemetrexed cisplatin or etoposide cisplatin plus thoracic radiation therapy followed by consolidation chemotherapy in locally advanced nonsquamous nonsmall cell lung cancer. J Clin Oncol 2016;34:

6 Panel Discussion References Vote NSCL F 2 of 4 the removal of the regimens: Adenocarcinoma, Large cell, NSCLC NOS (PS 0 1); carboplatin/vinorelbine, cisplatin/vinorelbine. Adenocarcinoma, Large cell, NSCLC NOS (PS 2); carboplatin/vinorelbine, etoposide, irinotecan, vinorelbine. NSCL F 3 of 4 the removal of the regimens: Squamous cell carcinoma (PS 0 1); carboplatin/etoposide, carboplatin/vinorelbine, cisplatin/gemcitabine/necitumumab cisplatin/vinorelbine. Squamous cell carcinoma (PS 2); carboplatin/vinorelbine, cisplatin/gemcitabine/necitumumab etoposide, irinotecan, vinorelbine Because they are rarely used in the United States, the panel consensus was to remove the noted regimens: First line Systemic Therapy Options; Adenocarcinoma, Large cell, NSCLC NOS (PS 0 1); the following regimens removed: carboplatin/vinorelbine, cisplatin/vinorelbine. First line Systemic Therapy Options; Adenocarcinoma, Large cell, NSCLC NOS (PS 2); the following regimens removed: carboplatin/vinorelbine, etoposide, irinotecan, vinorelbine. Because they are rarely used in the United States, the panel consensus was to remove the noted regimens: First line Systemic Therapy Options; Squamous cell carcinoma (PS 0 1); the following regimens removed: carboplatin/etoposide, carboplatin/vinorelbine, cisplatin/gemcitabine/necitumumab, cisplatin/vinorelbine. First line Systemic Therapy Options; Squamous cell carcinoma (PS 2); the following regimens removed: carboplatin/vinorelbine, cisplatin/gemcitabine/necitumumab, etoposide, irinotecan, vinorelbine

7 Panel Discussion References Vote NSCL F 3 of 4 Submission from Eli Lilly and Company requesting review of the evidence and re evaluation of the category recommendation for inclusion of necitumumab. Submission from Upstage Lung Cancer supported above submission. NSCL H Institutional review comment suggesting the addition of vandetanib to the list of agents for RET rearrangements. submission, the panel consensus was to add the following footnote, Cisplatin/gemcitabine/necitumumab in the firstline setting and erlotinib or afatinib in the second line setting are not used at NCCN institutions for these indications related to the efficacy and safety of these agents compared to the efficacy and safety of other available agents. The combination regimen cisplatin/gemcitabine/necitumumab was removed from the Guidelines. Based upon review of the data in the noted references, the panel consensus was to add vandetanib (category 2A) as an available targeted agent with activity against RET rearrangements. See submission for references Lee S H, Lee J K, Ahn M J, et al. A phase II study of vandetanib in patients with non small cell lung cancer harboring RET rearrangement [abstract]. J Clin Oncol 2016;34: Abstract