NCCN Non-Small Cell Lung Cancer V Meeting June 15, 2018

Transcription

1 Guideline Page and Request Illumina Inc. requesting to replace Testing should be conducted as part of broad molecular profiling with Consider NGS-based assays that include EGFR, ALK, ROS1, and BRAF as part of a broad molecular profiling strategy. the clarification that the broad molecular 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 to inform the use of currently available biomarker driven therapies as well as clinical trial options. requesting footnote gg be changed from If repeat biopsy is not feasible, plasma biopsy should be considered to If broad molecular profiling for the seven genes with FDA-approved targeted drugs [EGFR, ALK, ROS1, BRAF, RET, MET (amplification and exon 14 skipping mutation), and ERBB2 (HER2) alterations] is incomplete, then broad molecular profiling utilizing either tissueor plasma-based comprehensive genomic profiling (CGP) is recommended. However, if plasmabased CGP testing does not identify any known oncogenic driver alteration in Panel Discussion/References Some labs use non-ngs technologies and the current wording does not prohibit NGS testing. consensus did not support these changes to the Guidelines. consensus did not support these changes to the Guidelines. The current wording is appropriate. Institution Vote YES NO ABSTAIN ABSENT

2 NSCLC then a repeat tissue biopsy is indicated. We additionally request that you define plasma-based comprehensive genomic profiling (CGP) as a plasma-based next-generation sequencing (NGS) test covering all four major classes of genomic alterations (point mutations, indels, fusions, and copy number amplifications), complete sequencing of the exons harboring targetable mutations, and inclusion of the mutually exclusive driver oncogenes in NSCLC. NSCL-18/NSCL-G 2 of 5 Boehringer-Ingelheim requesting to include first line treatment with afatinib, for patients with non resistant mutations. consensus was to make no change to the current listing of afatinib on NSCL-18, as this information is noted in the Principles of Molecular and Biomarker Analysis (NSCL-G 2 of 5). NSCL-18/NSCL-G 2 of 5 AstraZeneca requesting the addition of treatment recommendations that includes osimertinib for the uncommon mutations (G719X, L861Q and S768I) in a separate algorithm from the listing of the common sensitizing mutations (exon 19 deletions and L858R). NSCL-19 requesting to change footnote pp If tissue biopsy is not feasible, plasma biopsy should be considered to Plasma- or tissue-based genotyping should be considered at progression on TKIs for EGFR, ALK, ROS1, RET or MET. Then keep Consider reflex to tissue-based testing, if plasma-based CGP is negative. consensus was to not make this change to the current listing of osimertinib on NSCL-18, as this information is noted in the Principles of Molecular and Biomarker Analysis (NSCL-G 2 of 5). consensus supported a change to the Guidelines and the footnote was modified. Plasma-based testing should be considered at progression on EGFR TKIs for the T790M mutation. If plasma-based testing is negative, tissue-based testing with rebiopsy material is strongly recommended. Practitioners may want to consider scheduling the biopsy concurrently with plasma testing referral.

3 NSCL-20/NSCL-21/NSCL-22/NSCL-27 AstraZeneca, requesting the addition of durvalumab as an option for patients with NSCLC who have recurrent or progressive disease, wherever appropriate in the guidelines. NSCL-21 External request from Genentech, requesting the review of updated data for central nervous system efficacy results from the Phase III ALEX trial. NSCL-25 Novartis, requesting the removal of the footnote: At this point, there are no published data on the progression free survival (PFS) of patients treated in the first line setting. NSCL-26 requesting to change PD-L1 expression (> 50%) and EGFR, ALK, ROS1, BRAF, negative or unknown by replacing or unknown with by tissueand/or plasma-based CGP, and adding MET as a target. consensus supported this change to the Guidelines and removed the footnote. consensus did not support these changes to the Guidelines. The current wording is appropriate. NSCL-26 Merck & Co., requesting the addition of pembrolizumab monotherapy as firstline treatment of patients with metastatic NSCLC of any histology whose tumors have PD-L1 expression tumor proportion score (TPS) 1% as determined by an FDA-approved test, with no sensitizing EGFR or ALK genomic tumor aberrations as a category 1. consensus did not support these changes to the Guidelines.

4 NSCL-27/NSCL-28 Eli Lilly and Company requesting listing ramucirumab plus docetaxel as a preferred second-line therapy for patients with NSCLC who are refractory to or have rapidly progressed on platinum-based chemotherapy in the first-line setting. NSCL-27/NSCL-28/NSCL-I 1 of 3 Bristol-Myers Squibb requesting the inclusion of the following footnote: nivolumab FDA approved dose is 240mg IV every 2 weeks or 480mg IV every 4 weeks administered over 30 minutes until disease progression or unacceptable toxicity. NSCL-28 Boehringer-Ingelheim requesting to include afatinib for the treatment of patients with advanced squamous cell carcinoma of the lung following progression on or after platinum based chemotherapy. NSCL-D Bristol-Myers Squibb requesting the review of data evaluating the neoadjuvant and adjuvant use of nivolumab with or without chemotherapy. NSCL-E AstraZeneca, requesting the review of data for gefitinib as adjuvant therapy in NSCLC. consensus did not support this level of specificity in the Guidelines; therefore, this change was not made. consensus did not support the addition of afatinib as an option in second-line therapy for patients with metastatic squamous cell carcinoma of the lung.

5 NSCL-G the inclusion of guidance regarding the measurement of TMB in the Principles of Molecular and Biomarker Analysis. NSCL-H Bristol-Myers Squibb, requesting the review of data for nivolumab in combination with ipilimumab as first-line therapy in patients with stage IV or recurrent NSCLC whose tumors have a tumor mutational burden (TMB) of 10 mutations/megabase, regardless of PD- L1 expression. NSCL-H the inclusion of Tumor Mutational Burden (TMB) in the list of biomarkers that should be tested as part of the work-up of a patient with metastatic NSCLC. Based upon review of the data in the noted reference, the panel consensus supported the addition of nivolumab ± ipilimumab as a category 2A recommendation to the section, "Emerging Biomarkers to Identify Patients for Therapies for Tumor Mutational Burden. The following footnote added: TMB is an evolving biomarker that may be helpful in selecting patients for immunotherapy. There is no consensus on how to measure TMB. Based upon review of the data in the noted reference, the panel consensus supported the addition of Tumor Mutational Burden to the section, "Emerging Biomarkers to Identify Patients for Therapies. The following footnote added: TMB is an evolving biomarker that may be helpful in selecting patients for immunotherapy. There is no consensus on how to measure TMB.