BREAST. An Observational Cohort Study Of Treatment Patterns And Outcomes In Patients With Her2 Positive (Her2+) Metastatic Breast Cancer

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1 BREAST Triple negative ABI-007-MBC-001 TnAcity NCT A phase 2/3, multi-center, open-label, randomize3d study of weekly nab-paclitaxel in combination with gemcitabine or carboplatin, compared to gemcitabine/ carboplatin, as first-line treatment in subjects with ER,PR and HER2 negative (triple negative) metastatic breast cancer ECOG 0-1 Path confirmed metastatic breast ca Path confirmed triple neg by central lab at screening Measurable disease by RECIST1.1 NO prior cytotoxic chemo for metastatic breast cancer > 30 days post neo adjuvant or adjuvant chemo Rad Tx at least 2 weeks prior w/measurable disease outside portal or evidence of progression post RadTx. BRCA 1 or 2 ABBOTT M BROCADE NCT A Randomized, Phase II Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel versus Placebo plus Carboplatin and Paclitaxel in Subjects with BRCA 1 or BRCA 2 mutation and Histological or cytological confirmed breast cancer w/ evidence of metastatic disease Must have BRCA 1 or 2 mutation One measurable lesion ECOG PS 0-2 If HER-2 positive, must have progressed on at least 1 prior standard HER2 directed therapy HER + MBC third line PUMA- NER-1301 NALA NCT A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients with Her2+ Who Have Received Two or More Prior Her2-Directed Regimens in the Setting (NALA) Histologically confirmed MBC; stage IV HER2+ (IHC3+ or FISH+), by central lab Prior tx w/> two (2) HER2-directed regimens for MBC >1 measurable metastatic lesion by RECIST v1.1 LVEF >50% by MUGA or ECHO; ECOG status of 0 or 1 Exclusions: Prior treatment with capecitabine, neratinib, lapatinib, HER2 directed TKI Cumulative exposure to anthracyclines: see protocol Active CNS metastases; Active uncontrolled cardiac disease: QTc interval >0.450 sec or hx of QTc prolongation or TdP HER2 + Genentech ML28257 SystHERs An Observational Cohort Study Of Treatment Patterns And Outcomes In Patients With Her2 Positive (Her2+) Her2+ MBC within 6 months of enrollment Excludes prior systemic therapy started > 6 month of enrollment All staged NCT FUJIREBIO DIAGNOSTICS FDI - 69 A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients with Histologic/pathologic confirmation of breast ca Any stage of disease; Any treatment time point: Life expectancy > 6 months If HX other cancers must be >5 years in remission updated Page 1 of 5

2 HER2 or Locally Advanced Unresetable BRCA Associated HER2 + Neoadjuvant, Locally advanced, Inflammatory or Early Stage Liver Humanitarian Device TX AbbVie M NCT Hoffman-La Roche MDS Nordion Contact Dr. George Khoriaty M12-914: A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative or Locally Advanced Unresectable BRCA-Associated WO29217: A Multicenter, Multinational, Phase II Study To Evaluate Pertuzumab In Combination With Trastuzumab And Standard Neoadjuvant Anthracycline-Based Chemotherapy In Patients With Her2-Positive, Locally Advanced, Inflammatory, Or Early-Stage [Berenice] GASTROINTESTINAL Treatment of Unresectable Hepatocellular Carcinoma with TheraSphere (Yttrium-90 Glass Microspheres): An HDE Treatment Protocol Histologicallyor cytologically confirmed breast cancer advanced or metastatic Suspected deleterious or deleterious BRCA1 or BRCA2 germline mutation HER2 negative Measurable or non-measurable disease ECOG st, 2 nd or 3 rd line Male or female locally advanced, inflammatory or early stage unilateral and histologically confirmed invasive breast cancer Inflammatory must be able to have a core biopsy Primary tumor >2cm in diameter, or >5 mm in diameter and node-positive (clinically on imaging or on cytology/histopathology HER2-Positive-local lab and-must be sent to central lab Prior to enrollment Baseline LVEF 55% ECOG 0-1 Hepatocellular carcinoma of the liver ECOG PS score of 2 with a life expectancy of > 3 months > 4 weeks since prior RT or surgery > 1 month post other chemotherapy. Excludes contraindications to angiography and selective visceral catheterization Excludes extra-hepatic disease representing an imminent lifethreatening outcome or active infection Surgically Resected 1 st line adjuvant ABI-007-PANC-003 APACT NCT Phase 3, Multicenter, Open-Label, Randomized Study Of nab - Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone As Adjuvant Therapy In Subjects With Surgically Resected Adenocarcinoma Resected ductal pancreatic adenoca w/ macroscopic resection (R0 and R1). T 1-3, N0-1, M0. 3. start treatment < 12 weeks postsurgery. (ECOG) PS 0-1. excluded neuroendocrine (and mixed type) tumors Borderline/ unresectable New Link Genetics NLG-0505 NCT A Phase Iii Study Of Chemotherapy With Or Without Hyperacute -Pancreas (Algenpantucel-L) Immunotherapy In Subjects With Borderline Resectable Or Locally Advanced Unresectable Cancer Borderline resectable or locally advanced unresectable pancreatic cancer with no metastatic ECOG < 1 Exclusion Prior chemo or Rad Tx for pancreas CA Exclusion Peripheral neuropathy > grade 2 updated Page 2 of 5

3 FUJIREBIO DIAGNOSTICS PILLAR A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Cancer Histologic/pathologic confirmation of exocrine pancreatic ca Any stage of disease; Any treatment time point: Life expectancy > 6 months If HX other cancers must be >5 years in remission. FDI - 68 Pancreas Incyte The JANUS 1 Study A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor, Ruxolitinub or Placebo in Combination With Capecitabine in Subjects With Advanced or Adenocarcinoma of the Pancreas Who Have Faliled or Are Intoloerant to First-Line Chemotherapy Advanced adenocarcinoma of the pancreas that is inoperable or metastatic Modified Glasgow Prognostic Score (mgps) of 1 or 2 as defined below: a) mgps of 1: CRP> 10mg/Land albumin > or35 g/l b) mgps of 2: CRP >10mg/L and albumin<35 g/l Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy) ECOG performance status 0 to 2 EXCLUSION Known brain or central nervous system metastases or history of uncontrolled seizures PNH - Renal Alexion M PNH Registry NCT MM Relapsed or Refractory CC-4047-MM-007 OPTIMISIMM NCT GENITOURINARY HEMATOLOGY ANEMIA Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry LEUKEMIA MULTIPLE MYELOMA A Phase 3, Multicenter, Randomized, Open label Study To Compare The Efficacy And Safety Of Pomalidomide, Bortezomib And Low-Dose Dexamethasone Versus Bortezomib And Low-Dose Dexamethasone In Subjects With Relapsed Or Refractory Multiple Myeloma MELANOMA Diagnosis of PNH Prior treatment with Solaris acceptable Measureable disease by serum and urine protein electrophoresis At least 1 but no more than 3 Prior tx Prior tx with Lenalidomide (at least 2 cycles) Documented disease progression after last anti-mm tx EXCLUSION: Refractory to Bortezomib (1.3mg/m 2 2x-wk); Non-secretory MM; Dialysis; Peripheral Neuropathy Grade 3 or 4 or 2 w/pain updated Page 3 of 5

4 Melanoma Adjuvant ECOG 1609 NCT Arms B & C Closing 8/15/2014 A Phase III, Randomized Study of Adjuvant Ipilimumab Anti- CTLA4 Therapy Versus High-Dose Interferon a - 2b for Resected High-Risk Melanoma *3rd Arm Added* HOLD pediatrics only Diagnosis of melanoma of a cutaneous origin or unknown primary Stage IIIB, IIIC, or IV (M1a or M1b) disease Complete resection with negative margins on resected specimens within past 12 weeks Recurrence after adequate surgical excision of original primary cutaneous melanoma allowed LUNG NSCLC Adv. Stage IIIB/IV Synta GALAXY2 NCT A Randomized, Phase 3 Study Of Ganetespib In Combination With Docetaxel Versus Docetaxel Alone In Patients With Advanced Non-Small-Cell Lung Adenocarcinoma Pre-dominate Adenocarcinoma. Progression following 1 st line tx for adv Only 1 prior systemic tx for IIIB/IV w/ platinum regime progression on or following Adv tx Prior tx for Stage I, II or IIIA allowed Measurable disease; Archived tissue available Dx Stage IIB/IV > 6 months prior to ICF NSCLC Stage IV 1 st Line SWOG S0819 NCT A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/ Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) ON HOLD per SWOG Newly diagnosed stage IV, advanced or recurrent disease after surgery and/or irradiation Controlled brain metastasis acceptable No prior chemotherapy, monoclonal antibody, EGFR, or VEGF targeted agents NSCLC Non-Squamous Recurrent or 2nd Line PrECOG-0502 MO22097 AVA ALL NCT An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patient with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy Locally recurrent or metastatic non-sq NSCLC ECOG Performance Status 0-2 Progressed beyond 1st line treatment with bev + a platinum doublet-containing chemotherapy Bev (monotherapy) maintenance treatment At least 1 un-dimensionally measurable lesion meeting RECIST criteria NSCLC-SQM CELGENE ABI-007-NSCL-003 ABOUND.SQM NCT A Phase III, Randomized, Open-Label, Crossover, Multi-Center, Safety And Efficacy Study To Evaluate Nab-Paclitaxel (Abraxane ) As Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin In Subjects With Squamous Cell Non-Small Cell Lung Cancer Stage IIIB or IV SQ NSCLC No Prior chemo for metastatic (prior adjuvant >12 months allowed) Measureable disease w/target lesion in non-radiated area. Exclusion: Active brain mets; peripheral neuropathy > grade 2 updated Page 4 of 5

5 LUNG SCLC 1 st line BAY NCT Bay in combination with cisplatin/etoposide or carboplatin/etoposide as first line therapy in patients with SCLC. extensive-stage disease SCLC At least 1 solid tumor lesion measurable by CT or MRI ECOG PS of 0-1 Exclusion Criteria: Prior systemic Tx for SCLC (including previous therapy with a CDK inhibitor) SCLC 2 nd line LS or ES Millennium C14018 NCT C14018: A Randomized, Double-blind, Placebocontrolled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC). Progressed after 1 st line platinum chemo SOC No 2 nd line chemo for relapsed or progression Progressed within 180 days of 1 st line tx Tx to start no earlier than 21 days post 1 st line. Advanced Non Small Cell Lung Cancer-1 st Line- Elderly ubjects NSCL IIIB with Pleural/Pericardi al effusion, Stage IV or Recurrent- Initial Treatment ABI-007-NSCL-005 ABOUND.70+ Incyte NCT ABI-007-NSCL-005: Safety and Efficacy Of Continuous Weekly nab-paclitaxel Vs. With 1 Week Break, In Combination With Carboplatin As First Line Treatment In Elderly Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): a Phase IV Randomized, Open- Label, Multi-Center Study INCB : A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and PemetrexedMaintenance for Initial Treatment of Subjects With Nonsquamous Non- Small cell Lung Cancer That is Stage IIIB with Pleural/Pericardial Effusion, Stage IV or Recurrent Age > 70 years at the time of signing the ICF Histologically or cytologically confirmed locally advanced or metastatic NSCLC who are not candidates for curative surgery or radiation Radiographically documented measurable disease (defined by the presence of > radiographically documented measurable lesion) No prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to signing the ICF and without disease recurrence. ECOG performance status 0 or 1 ECOG performance status 0 or 1 Subjects must not have received prior chemotherapy for advanced or metatstatic disease Life expectancy of at least 12 weeks Radiographically measurable or evaluable disease mgps of 1 or 2 updated Page 5 of 5