2016 biomedtacker pre asco report - extract
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May 2016 / 1
2016 Biomedtracker Pre-ASCO Report
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Pre-ASCO Report 2016
AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETINGCHICAGO, ILLINOIS • JUNE 3-7, 2016
Extract
May 2016 / 5
2016 Biomedtracker Pre-ASCO Report
Companies to Watch
TRACON Pharmaceuticals (TCON) Poster abstract #2035 (June 4, 2016)
First data for TRC105 in GBM
Phase II results with bevacizumab show positive OS efficacy in small number of patients
New data complement development of TRC105 in a range of tumor types
Small pipeline of only two clinical-stage drugs
Bottom line – Positive for TCON
Ariad Pharmaceuticals (ARIA) Oral abstract 9007 (June 6, 2016)
Positive pivotal top-line data in NSCLC
Could become only second FDA approved therapy for ALK mutation patients
First step on way to head-to-head study against Xalkori (crizotinib) for 1L ALK patients
Bottom line – Positive for ARIA
ImmunoGen (IMGN) Poster abstract #5567 (June 6, 2016)
Updated Phase I results for mirvetuximab soravtansine for ovarian cancer
Biomarker results inform enrollment design of next Phase Ib/II study
Potential combination with immunotherapy
Bottom line – Positive for IMGN
NewLink Genetics (NLNK) Poster abstracts 3075 and 3020 (June 5, 2016)
No news is bad news – little progress amid questions on pipeline
IDO targeted therapy with questionable MOA
No progress in HyperAcute therapies
Bottom line – Negative for NLNK
Juno Therapeutics (JUNO) Oral abstract 7003 (June 4, 2016)
In race for first approvals of any CAR-T therapies
Updated data for JCAR015 provide rationale for earlier use in treatment paradigm
Bottom line – Positive for JUNO Novartis (NVS)
Restructuring of Pharma division to separate oncology unit from rest of Pharma
Elevates oncology division
Likely minor market impact
Bottom line – Positive for NVS
May 2016 / 6
2016 Biomedtracker Pre-ASCO Report
Notable Late Breaking Abstracts (LBAs)
Darzalex for Multiple Myeloma (MM) (JNJ) Abstract LBA4: Phase III randomized controlled study of daratumumab, bortezomib, and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR study This is the sole presentation of drug development interest in the Plenary session and should reveal the first quantitative data from CASTOR. Darzalex received accelerated approval in November 2015 as a fourth-line treatment for multiple myeloma, but positive results from CASTOR could advance the antibody therapy into a second-line setting (in combination with bortezomib and dexamethasone). An interim analysis in March 2016 already disclosed that the study had met its primary PFS endpoint. Along with the anticipated CASTOR results, top-line data from the Phase III – POLLUX study that are not to be presented at ASCO were released separately. POLLUX is also evaluating Darzalex in the R/R setting but in combination with lenalidomide/dexamethasone. The release shows that the trial met its primary PFS endpoint with a HR of 0.37 (p<0.0001), although the median PFS for the treatment arm has not yet been reached. These positive results from two pivotal trials will be key for both for the full approval of Darzalex and its advancement earlier into the treatment paradigm. Additionally, the figure below, provided by Datamonitor Healthcare, depicts the projected sales forecast for Darzalex through 2024.
Source: Datamonitor Healthcare
Lead Company Symbol Drug Indication Phase Trial Name(s) Event Type Link
AbbVie Inc. ABBV Veliparib Ovarian Cancer II Phase I/II - Veli-BRCA Trial Data - Top-Line Results 210483
AbbVie Inc. ABBV Venclexta Acute Myelogenous Leukemia (AML) II Phase Ib - w/Decitabine or Azacitidine (Elderly) Trial Data - Updated Results 210474
AbbVie Inc. ABBV Venclexta Acute Myelogenous Leukemia (AML) II Phase I/II - w/LDAC (Elderly) Trial Data - Top-Line Results 210477
AbbVie Inc. ABBV VenclextaChronic Lymphocytic Leukemia (CLL)/Small Cell
Lymphocytic Lymphoma (SLL) - NHLApproved Phase I - M12-175 (CLL/NHL) Trial Data - Updated Results 210504
Adaptimmune Ltd. ADAP AFP TCRHepatocellular (Liver) Cancer (HCC) (including
secondary metastases)IND Preclinical Studies Trial Data - Preclinical Results 210480
Angiochem, Inc. ANG1005 Brain Cancer (secondary; metastases) II Phase II - HER2+ Trial Data - Top-Line Results 210484
ARIAD Pharmaceuticals, Inc. ARIA Brigatinib Non-Small Cell Lung Cancer (NSCLC) III Phase II - ALTA (Crizotinib-Resistant) Trial Data - Top-Line Results 210463
Array BioPharma, Inc. ARRY Binimetinib Melanoma III Phase III - NEMO - vs Dacarbazine (NRAS) Trial Data - Updated Results 210464
Array BioPharma, Inc. ARRY Encorafenib Colorectal Cancer (CRC) II Phase Ib/II - w/Cetuximab or w/Cetuximab/BYL719 Trial Data - Updated Results 210470
AstraZeneca PLC AZN Acalabrutinib Pancreatic Cancer II Phase II - +/-Pembrolizumab Trial Data - Top-Line Results 210479
AstraZeneca PLC AZN Durvalumab Non-Small Cell Lung Cancer (NSCLC) III Phase I/II - Monotherapy (Solid Tumors) Trial Data - Subgroup Analysis 210503
Bristol-Myers Squibb Company BMY Opdivo Gastric Cancer II Phase I/II - CheckMate 032 (w/Ipilimumab) Trial Data - Updated Results 210505
Bristol-Myers Squibb Company BMY Opdivo Non-Small Cell Lung Cancer (NSCLC) Approved Phase Ib - Checkmate 012 Trial Data - Updated Results 210496
Bristol-Myers Squibb Company BMY Opdivo Melanoma Approved Phase III - CheckMate 067 - vs. Ipilimumab Trial Data - Updated Results 210490
Bristol-Myers Squibb Company BMY Opdivo Colorectal Cancer (CRC) II Phase I/II - CheckMate 142 (w/ Ipilimumab) Trial Data - Top-Line Results 210471
Bristol-Myers Squibb Company BMY Opdivo Brain Cancer (Malignant Glioma; AA and GBM) III Phase III - w/Ipilimumab (CheckMate 143) Trial Data - Updated Results 210473
Bristol-Myers Squibb Company BMY Opdivo Non-Small Cell Lung Cancer (NSCLC) ApprovedPhase III - CheckMate 017 (Squamous; vs. Docetaxel),
Phase III - CheckMate 057 (Non-Squamous; vs. Docetaxel)Trial Data - Updated Results 210460
Bristol-Myers Squibb Company BMY Yervoy Gastric Cancer II Phase II - vs. SoC after Chemo Trial Data - Top-Line Results 210506
Celator Pharmaceuticals, Inc. CPXX Vyxeos Acute Myelogenous Leukemia (AML) III Phase III - 301 - Secondary AML Trial Data - Final Results 210485
Celgene Corporation CELG Abraxane Breast Cancer Approved Phase III - ETNA Trial Data - Top-Line Results 210495
Eli Lilly & Company LLY Abemaciclib Breast Cancer III Phase II - MONARCH 1 (HR+, HER2-) Trial Data - Top-Line Results 210486
Exelixis, Inc. EXEL Cabometyx / Cometriq Renal Cell Cancer (RCC) Approved Phase III - METEOR (vs. Everolimus) Trial Data - Final Results 210482
Five Prime Therapeutics, Inc. FPRX FPA144 Gastric Cancer I Phase Ia/Ib - Dose Escalation Trial Data - Updated Results 210501
Gilead Sciences, Inc. GILD ZydeligChronic Lymphocytic Leukemia (CLL)/Small Cell
Lymphocytic Lymphoma (SLL) - NHLApproved Phase III - 0115 (w/Bendamustine/Rituximab; Previously Treated) Trial Data - Updated Results 210491
ImmunoGen, Inc. IMGN Mirvetuximab soravtansine Ovarian Cancer II Phase I - FOLR1-Positive Trial Data - Updated Results 210459
Juno Therapeutics Inc. JUNO JCAR015 Acute Lymphocytic Leukemia (ALL) II Phase I - Adults (MSKCC) Trial Data - Updated Results 210492
Merck & Co., Inc. MRK Keytruda Non-Small Cell Lung Cancer (NSCLC) Approved Phase I/II - KEYNOTE-021 Trial Data - Updated Results 210493
Merck & Co., Inc. MRK Keytruda Melanoma Approved Phase III - KEYNOTE-006 (vs. Ipilimumab) Trial Data - Final Results 210461
Merck & Co., Inc. MRK Keytruda Melanoma Approved Phase Ib - KEYNOTE Study 001 (Solid Tumors) Trial Data - Updated Results 210462
Merck & Co., Inc. MRK Keytruda Brain Cancer (Malignant Glioma; AA and GBM) Investigator Initiated Phase II - Recurrent Glioblastoma (Dana-Farber) Trial Data - Top-Line Results 210469
Merck & Co., Inc. MRK Keytruda Head and Neck Cancer NDA/BLA Phase II - KEYNOTE-055 (HNSCC Patients) Trial Data - Top-Line Results 210475
Merck & Co., Inc. MRK Keytruda Hodgkin's Lymphoma II Phase II - KEYNOTE-087 Trial Data - Top-Line Results 210466
Merck KGaA MKGAY Avelumab Mesothelioma I Phase I - JAVELIN Solid Tumor Trial Data - Updated Results 210502
Merck KGaA MKGAY Avelumab Gastric Cancer III Phase I - JAVELIN Solid Tumor Trial Data - Updated Results 210508
NewLink Genetics Corporation NLNK Indoximod Melanoma II Phase Ib/II - NLG2103 (+Ipilimumab) Trial Data - Updated Results 210509
NewLink Genetics Corporation NLNK Indoximod Pancreatic Cancer II Phase Ib/II - w/Gemcitabine + Nab-Paclitaxel Trial Data - Updated Results 210510
Novartis AG NVS CTL019Chronic Lymphocytic Leukemia (CLL)/Small Cell
Lymphocytic Lymphoma (SLL) - NHLII Phase II - Abramson Cancer Center (Penn) Trial Data - Updated Results 210472
Novartis AG NVS Tafinlar Non-Small Cell Lung Cancer (NSCLC) II Phase II - 113928 Trial Data - Updated Results 210494
NovoCure Limited NVCR Optune Pancreatic Cancer Development Outside U.S. Phase I/II - PANOVA (Study EF-20; EU) Trial Data - Subgroup Analysis 210447
OBI Pharma, Inc. OBI-822 Breast Cancer III Phase II/III - OPT-822-001 Trial Data - Updated Results 210488
Pfizer Inc. PFE Ibrance Breast Cancer Approved Phase III - PALOMA-3 - w/Fulvestrant (HR+/HER2-) Trial Data - Subgroup Analysis 210481
Pfizer Inc. PFE Ibrance Breast Cancer Approved Phase II/III - PALOMA-2 - w/Letrozole (ER+/HER2-) Trial Data - Updated Results 210499
Pfizer Inc. PFE PF-05082566 Solid Tumors II Phase I/II - KEYNOTE-0036 (w/MK-3475) Trial Data - Top-Line Results 210507
Roche Holding AG RHHBF Alecensa Non-Small Cell Lung Cancer (NSCLC) Approved Phase III - J-ALEX (vs. Crizotinib; Naïve Anaplastic) Trial Data - Updated Results 210457
Roche Holding AG RHHBF RG7888 Solid Tumors I Phase I - w/RG7446 Trial Data - Top-Line Results 210489
Roche Holding AG RHHBF Taselisib Breast Cancer III Phase I/II - Solid Tumors/HR+ mBC Trial Data - Top-Line Results 210497
Roche Holding AG RHHBF Tecentriq Non-Small Cell Lung Cancer (NSCLC) NDA/BLA Phase II - POPLAR vs. Docetaxel (After Platinum Failure) Trial Data - Updated Results 210476
Syndax Pharmaceuticals, Inc. SNDX Entinostat Non-Small Cell Lung Cancer (NSCLC) II Phase Ib/II - w/Pembrolizumab (NSCLC/Melanoma) Trial Data - Top-Line Results 210465
Threshold Pharmaceuticals, Inc. THLD Evofosfamide Pancreatic Cancer Suspended Phase III - MAESTRO (vs. Gemcitabine) Trial Data - Updated Results 210487
TRACON Pharmaceuticals, Inc. TCON TRC105 Brain Cancer (Malignant Glioma; AA and GBM) II Phase II - 105GM201 - w/Bevacizumab Trial Data - Top-Line Results 210468
ZIOPHARM Oncology, Inc. ZIOP Ad-RTS IL-12 Brain Cancer (Malignant Glioma; AA and GBM) I Phase I - w/Veledimex (Grade III) Trial Data - Updated Results 210454
List of Biomedtracker ASCO Events
May 2016 / 2
2016 Biomedtracker Pre-ASCO Report
Summary Abstracts from the 52nd Annual meeting of the American Society of Clinical Oncology (ASCO) were released May 18th at 5pm EDT. The 2016 ASCO meeting will be held in Chicago, Illinois from June 3-7,
2016.
We have highlighted some key abstracts with analyses, along with companies to watch during the meeting. While this is just a brief overview, we will be available to discuss any data of interest in further detail. Please email Biomedtracker or call your sales representative. Additionally, keep an eye out for our ASCO weekend updates and live-coverage when the meeting takes place.
About the Author Biomedtracker is an independent research service that offers proprietary clinical assessments and patient-based revenue forecasts of developmental drugs within a comprehensive and intuitive drug information database. Clients from the pharmaceutical, biotech, and investment industries rely on Biomedtracker for its insight on the likelihood of approval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape of every important disease and indication. Over the last several years, Biomedtracker has become the leader in providing objective information alongside evidence based clinical assessments and investment research on pipeline drugs worldwide. For more information on getting direct access to Biomedtracker, please email [email protected].
Disclaimer All abstracts reprinted with permission © 2016 American Society of Clinical Oncology. All rights reserved. This is not a product sponsored by ASCO.