Updates in Lung Cancer from ASCO 2016 Alectinib versus Crizotinib - PDF document

7/20/2016 Updates in Lung Cancer from ASCO 2016 Alectinib versus Crizotinib in ALK Inhibitor Naïve ALK-Positive Non-Small Cell Lung Cancer:<br /> Primary Results from the J-ALEX Study Presented By Hiroshi Nokihara at 2016 ASCO Annual Meeting 1

7/20/2016 J-ALEX Phase III Study Design Presented By Hiroshi Nokihara at 2016 ASCO Annual Meeting Common AEs, ≥20% of Patients in Either Arm Presented By Hiroshi Nokihara at 2016 ASCO Annual Meeting 2

7/20/2016 Primary Endpoint: PFS by IRF (ITT Population) Presented By Hiroshi Nokihara at 2016 ASCO Annual Meeting Subgroup Analysis of PFS by IRF Presented By Hiroshi Nokihara at 2016 ASCO Annual Meeting 3

7/20/2016 Brigatinib in Patients With Crizotinib-Refractory ALK+ Non – Small Cell Lung Cancer: First Report of Efficacy and Safety From a Pivotal Randomized Phase 2 Trial (ALTA) Presented By Dong-Wan Kim at 2016 ASCO Annual Meeting Brigatinib Antitumor Activity by Arm Presented By Dong-Wan Kim at 2016 ASCO Annual Meeting 4

7/20/2016 PFS by Arm Presented By Dong-Wan Kim at 2016 ASCO Annual Meeting Survival by Arm Presented By Dong-Wan Kim at 2016 ASCO Annual Meeting 5

7/20/2016 Brigatinib CNS Antitumor Activity by Arm Presented By Dong-Wan Kim at 2016 ASCO Annual Meeting Safety and Efficacy of Lorlatinib (PF-06463922) From the Dose Escalation Component of a Study in Patients With Advanced ALK+ or ROS1+ Non-Small-Cell Lung Cancer Presented By Benjamin Solomon at 2016 ASCO Annual Meeting 6

7/20/2016 Phase I Design and Patient Population <br />of an Ongoing Phase I/II Study Presented By Benjamin Solomon at 2016 ASCO Annual Meeting Treatment- Related Adverse Events in <br />≥15% of Patients Treated at the RP2D Presented By Benjamin Solomon at 2016 ASCO Annual Meeting 7

7/20/2016 Clinical Activity: <br />Progression-Free Survival in ALK+ Patients Presented By Benjamin Solomon at 2016 ASCO Annual Meeting Majority of ROS1 Patients Had a <br />Decrease in Target Lesion Size* Presented By Benjamin Solomon at 2016 ASCO Annual Meeting 8

7/20/2016 CNS Responses in ALK/ROS1+ Patients<br />with Measurable Disease Presented By Benjamin Solomon at 2016 ASCO Annual Meeting Antitumor Activity and Safety of Crizotinib <br />in Patients with Advanced MET Exon 14-Altered <br />Non-Small Cell Lung Cancer Presented By Alexander Drilon at 2016 ASCO Annual Meeting 9

7/20/2016 Slide 11 Presented By Alexander Drilon at 2016 ASCO Annual Meeting Osimertinib activity in patients with leptomeningeal disease from non-small cell lung cancer: <br />updated results from the BLOOM study Presented By James Yang at 2016 ASCO Annual Meeting 10

7/20/2016 BLOOM study design: osimertinib LM cohort 1 Presented By James Yang at 2016 ASCO Annual Meeting Osimertinib activity across LM assessments Presented By James Yang at 2016 ASCO Annual Meeting 11

7/20/2016 Changes in EGFRm DNA copy number in CSF <br />with osimertinib treatment Presented By James Yang at 2016 ASCO Annual Meeting Phase I study (BLOOM) of AZD3759, a CNS penetrable EGFR inhibitor, for the treatment of non-small-cell lung cancer (NSCLC) with brain metastasis (BM) and leptomeningeal metastasis (LM) Presented By Myung-Ju Ahn at 2016 ASCO Annual Meeting 12

7/20/2016 Intracranial tumor shrinkage according to dose Presented By Myung-Ju Ahn at 2016 ASCO Annual Meeting An Open-Label Phase 2 Trial of Dabrafenib in Combination With Trametinib in Patients With Previously Treated BRAF V600E – Mutant Advanced <br />Non-Small Cell Lung Cancer (BRF113928) Presented By David Planchard at 2016 ASCO Annual Meeting 13

7/20/2016 Maximum Change in Target Lesion by Best Investigator-Assessed Confirmed Response Presented By David Planchard at 2016 ASCO Annual Meeting Progression-Free Survival Presented By David Planchard at 2016 ASCO Annual Meeting 14

7/20/2016 Most Common AEs (≥ 20%) Presented By David Planchard at 2016 ASCO Annual Meeting Slide 1 Presented By D. Camidge at 2016 ASCO Annual Meeting 15

7/20/2016 Antibody Drug Conjugate: Sacituzumab Govitecan (IMMU-132) Presented By D. Camidge at 2016 ASCO Annual Meeting Adverse Events by Dose, All Causalities, All Grades in > 10% NSCLC Patients <br />and Grade 3+ in > 3% Patients (N=49 patients reporting at this time) Presented By D. Camidge at 2016 ASCO Annual Meeting 16

7/20/2016 Best Response By RECIST 1.1 (8 & 10 mg/kg) Presented By D. Camidge at 2016 ASCO Annual Meeting Trop-2 Staining and Best Initial Tumor Response (including unconfirmed responses) Presented By D. Camidge at 2016 ASCO Annual Meeting 17

7/20/2016 Progression-Free Survival and Overall Survival <br />(8 or 10 mg/kg; median of 3 prior therapies) Presented By D. Camidge at 2016 ASCO Annual Meeting Safety and efficacy of single agent rovalpituzumab tesirine (SC16LD6.5), a delta-like protein 3 (DLL3)-targeted antibody-drug conjugate (ADC) in recurrent or refractory small cell lung cancer (SCLC) Presented By Charles Rudin at 2016 ASCO Annual Meeting 18

7/20/2016 SCRX16-001: First-in-Human Study Schema Presented By Charles Rudin at 2016 ASCO Annual Meeting Adverse Event Profile in SCLC Subjects (n=74) Presented By Charles Rudin at 2016 ASCO Annual Meeting 19

7/20/2016 RECIST Confirmed Responses per Investigator Presented By Charles Rudin at 2016 ASCO Annual Meeting SCLC Kaplan-Meier Overall Survival Presented By Charles Rudin at 2016 ASCO Annual Meeting 20

7/20/2016 Favorable Comparison vs. Existing 2L and 3L CTX Presented By Charles Rudin at 2016 ASCO Annual Meeting CheckMate 012: Safety and Efficacy of First ‐ line Nivolumab and Ipilimumab in Advanced NSCLC Presented By Matthew Hellmann at 2016 ASCO Annual Meeting 21

7/20/2016 Phase 1 CheckMate 012 Study Design: <br />Nivolumab Plus Ipilimumab in First-line NSCLC Presented By Matthew Hellmann at 2016 ASCO Annual Meeting Nivolumab Plus Ipilimumab in First-line NSCLC:<br />Treatment-related Select AEs Presented By Matthew Hellmann at 2016 ASCO Annual Meeting 22

7/20/2016 Nivolumab Plus Ipilimumab in First-line NSCLC:<br />Summary of Efficacy Presented By Matthew Hellmann at 2016 ASCO Annual Meeting Nivolumab Plus Ipilimumab in First-line NSCLC:<br />Kinetics of Response Presented By Matthew Hellmann at 2016 ASCO Annual Meeting 23

7/20/2016 Nivolumab Plus Ipilimumab in First-line NSCLC:<br />Efficacy Across All Tumor PD-L1 Expression Levels Presented By Matthew Hellmann at 2016 ASCO Annual Meeting Local Consolidative Therapy (LCT) Improves Progression-Free Survival (PFS) in Patients with Oligometastatic Non-Small Cell Lung Cancer (NSCLC) who do not Progress after Front Line Systemic Therapy (FLST): Results of a Multi-Institutional Phase II Randomized Study Presented By Daniel Gomez at 2016 ASCO Annual Meeting 24

7/20/2016 Trial Design Presented By Daniel Gomez at 2016 ASCO Annual Meeting Trial Design Presented By Daniel Gomez at 2016 ASCO Annual Meeting 25

7/20/2016 PFS Outcomes (updated data) Presented By Daniel Gomez at 2016 ASCO Annual Meeting Prognostic Factors for PFS Presented By Daniel Gomez at 2016 ASCO Annual Meeting 26

7/20/2016 Time to New Site Failure (TNSF) Presented By Daniel Gomez at 2016 ASCO Annual Meeting Improved Overall Survival in Lung Cancer Patients <br />using a Webapplication-mediated Follow-up compared to Standard Modalities: <br />Results of a Phase III Randomized Trial Presented By Fabrice Denis at 2016 ASCO Annual Meeting 27

7/20/2016 Phase 3 multi-centric randomized study Presented By Fabrice Denis at 2016 ASCO Annual Meeting Overall Survival Improvement Presented By Fabrice Denis at 2016 ASCO Annual Meeting 28

7/20/2016 Quality of Life (mean score at 6 months) Presented By Fabrice Denis at 2016 ASCO Annual Meeting Other « intensive » clinical follow-up studies Presented By Fabrice Denis at 2016 ASCO Annual Meeting 29

7/20/2016 Slide 1 Presented By Heather Wakelee at 2016 ASCO Annual Meeting Slide 2 Presented By Heather Wakelee at 2016 ASCO Annual Meeting 30

7/20/2016 E1505 OS +/- Bevacizumab E1505 DFS+/- Bevacizumab Presented By Heather Wakelee at 2016 ASCO Annual Meeting Pooled Chemo Analysis (all patients regardless of treatment arm)<br /> OS by chemo group OS by chemo group <br />Non-squamous : Logrank p=0.18 Squamous: Logrank p=0.99 Presented By Heather Wakelee at 2016 ASCO Annual Meeting 31

7/20/2016 Pooled Chemo Analysis (all patients regardless of treatment arm)<br /> DFS by chemo group DFS by chemo group <br />Non-squamous : Logrank p=0.58 Squamous : Logrank p=0.83 Presented By Heather Wakelee at 2016 ASCO Annual Meeting CONVERT trial<br />Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited-stage small cell lung cancer and good performance status Presented By Corinne Faivre-Finn at 2016 ASCO Annual Meeting 32

7/20/2016 Study design multinational, phase III randomised study Presented By Corinne Faivre-Finn at 2016 ASCO Annual Meeting Overall survival Presented By Corinne Faivre-Finn at 2016 ASCO Annual Meeting 33