On May 18, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company developing novel antibody-drug conjugate (ADC) cancer therapeutics, reported the clinical data from a 46-patient Phase 1 cohort evaluating the efficacy and safety of mirvetuximab soravtansine as single-agent therapy for platinum-resistant, folate receptor alpha (FRα)-positive ovarian cancer (Press release, ImmunoGen, MAY 18, 2016, View Source [SID:1234512578]). These results have informed the Company’s selection of the patient population and primary endpoint for a Phase 3 study scheduled to begin before year-end.

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This Phase 1 cohort, which was expanded from 20 to 46 patients to provide additional information for the design of subsequent trials, enrolled patients with platinum-resistant ovarian cancer who had received up to five previous treatment regimens. Patients also needed to have FRα expressed at or above a predefined level on at least 25% of tumor cells. Patients were classified as having low, medium, or high FRα expression based on the percent of tumor cells meeting this criterion (25-49%, 50-74%, and 75-100%, respectively). Among the 46 patients, 23 had high, 14 had medium, and 9 had low expression of FRα. All had previously received platinum and a taxane.

Among all 46 patients, the confirmed objective response rate (ORR) was 26% and median progression-free survival (PFS) was 4.8 months (95% confidence interval, 3.9-5.7 months). Among the 16 patients who received up to three prior regimens and had high or medium FRα expression – the population selected for the planned Phase 3 trial – the ORR was 44% and median PFS was 6.7 months (95% CI, 3.9-11.0 months). For the 30 patients with low FRα and/or who had received four or five prior regimens, ORR was 17% and median PFS was 4.2 months (95% CI, 2.6-5.5 months).

Current single-agent therapies for platinum-resistant ovarian cancer typically have an ORR of 15-20% and median PFS of 3-4 months, including in patients receiving no more than two prior regimens.1

Based upon the findings in this Phase 1 cohort, the planned Phase 3 trial assessing mirvetuximab soravtansine as single-agent therapy for platinum-resistant ovarian cancer will enroll patients who previously received up to three treatment regimens and whose cancer has high or medium FRα expression, with PFS as the primary endpoint.

"There is a significant need for new therapies for ovarian cancer," commented Dr. Kathleen Moore, Christy Everest Endowed Chair in Cancer Research and Director of the Oklahoma TSET Phase I Unit, Stephenson Cancer Center, University of Oklahoma HSC. "We’re excited about the findings with mirvetuximab soravtansine from this study and to be advancing this first-in-class agent into a Phase 3 trial for platinum-resistant ovarian cancer."

"We plan to have Phase 3 testing of mirvetuximab soravtansine up and running by year end," commented Dr. Charles Morris, ImmunoGen’s EVP and Chief Development Officer. "Now that we have the full results from the 46-patient ovarian cancer cohort, we’ve submitted a meeting request to the FDA to discuss our proposed path to approval. This meeting should take place early in 3Q2016, and we are targeting initiation of FORWARD I Phase 3 testing in 4Q2016."

Mirvetuximab soravtansine was generally well tolerated, with most side effects Grade 1 or 2 (least severe grades). Of particular note, incidence of blurred vision was reduced from 55%, mostly Grade 2, in the first 20 patients enrolled to 39%, mostly Grade 1, among the 26 patients added with the expansion of the cohort. Other side effects reported in more than 20% of patients were diarrhea, fatigue, nausea, vomiting, peripheral neuropathy, increased AST, keratopathy, and abdominal pain.

Data Presentation at ASCO (Free ASCO Whitepaper) 2016

"IMGN853 (mirvetuximab soravtansine), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC): single-agent activity in platinum-resistant epithelial ovarian cancer patients" will be presented in the Gynecologic Cancer Poster Session (Poster Board #390) taking place on Monday, June 6, from 1:00-4:30 pm CT. (Abstract #5567).

About the Planned FORWARD I Phase 3 Trial

The FORWARD I Phase 3 trial is intended to support full marketing approval of mirvetuximab soravtansine for the treatment of patients with platinum-resistant ovarian cancer who previously received up to three treatment regimens for whom single-agent therapy is appropriate. The cancer also must have high or medium FRα expression. ImmunoGen estimates that 5,000-7,000 patients per year (US) meet these criteria.

Patients will be randomized 2:1 to mirvetuximab soravtansine or physician’s choice, which will include pegylated liposomal doxorubicin, topotecan, and weekly paclitaxel.

PFS will be the primary endpoint of the trial. This study also will be powered for separate assessment of the endpoint in the full study population and in the subset with high FRα expression and will include at least 300 patients.

About Mirvetuximab Soravtansine

Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

ImmunoGen is advancing mirvetuximab soravtansine into Phase 3 testing as a single agent for the treatment of platinum-resistant ovarian cancer. The product candidate is also in Phase 1b/2 testing in combination regimens for ovarian cancer.

About Ovarian Cancer and FRα

This year, approximately 22,300 new cases of ovarian cancer will be diagnosed in the US and more than 14,200 women will die from the disease.2 ImmunoGen estimates that 40% of ovarian cancer cases have high FRα expression, 20% have medium, 20% have low, and 20% have very low levels of FRα.

Standard first-line therapy for ovarian cancer is a platinum-based regimen. Once the cancer becomes platinum-resistant, patients may receive single-agent therapy.

On May 18, 2016 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, reported its financial results for the quarter ended March 31, 2016 along with an update on recent corporate developments (Press release, , MAY 18, 2016, View Source [SID:1234512602]).

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"We achieved several important milestones during the first quarter, including initiating our first trade as a public company," commented William Annett, Chief Executive Officer. "Operationally, we strengthened our management team and Board of Directors with seasoned healthcare professionals. Clinically, we made significant progress towards commercializing our first product, a confirmatory lung diagnostic, when we received positive research results from our development partner, The Wistar Institute.
"Currently, we are focused on attempting to lock down both the assay and the classifier or algorithm that interprets test results. If successful we plan to initiate an internal analytical validation study, a process to confirm whether the test results can be reproduced using our equipment and in our own lab. We expect this process to continue into the fourth quarter. If the validation study is successful we intend to implement our commercialization plans, including hiring a sales force, building out our commercial infrastructure, moving towards completion and obtaining CLIA certification of a diagnostic laboratory and ultimately launching our lung cancer diagnostic test in the first half of 2017," concluded Mr. Annett.

Recent Accomplishments
Entered into a definitive global licensing agreement with The Wistar Institute for a simple, non-invasive, blood test to aid physicians in the early detection of lung cancer. The agreement provides OncoCyte the exclusive rights to commercialize this lung cancer diagnostic test.

Received positive research results for the Company’s lung cancer diagnostic test being developed at The Wistar Institute. This study replicated a previous study that was carried out at Wistar and which was presented at the American Thoracic Society conference in May 2015.

Selected to have the Company’s bladder cancer abstract presented in a poster session at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago. The abstract will be released on May 18th at 4pm CT on ASCO (Free ASCO Whitepaper)’s website and a live panel discussion led by Karen Chapman, VP Research will be held on June 6th, 2016 at 4:45pm CT.

First Quarter 2016 Financial Results
The Company is still in the development stage and will not generate revenue until after the commercial launch of its lung test.
The net loss for the quarter ended March 31, 2016 was $2.9 million, or $0.12 per share, compared to $1.4 million, or $0.08 per share, in 2015.

Research and development expenses for the quarter ended March 31, 2016 increased to $1.7 million from $1.1 million for the same period in 2016. These increases were primarily the result of increased spending on outside research services, scientific consulting services, clinical trial related expenses, and laboratory expenses. These increases were in part offset by a $104,000 decrease in stock based compensation expenses to employees and consultants allocated to research and development expense.
General and administrative expenses increased to $1.2 million from $250,000 for the same period in 2015. These increases are primarily as a result of increased salary and payroll related expenses, general consulting expenses, accounting and audit related expenses, transfer agent, stock listing and SEC filing expenses.

At March 31, 2016, OncoCyte had $5.9 million of cash and cash equivalents and available-for-sale securities valued at $1.8 million, which OncoCyte may use for working capital purposes, as necessary.

Conference Call
OncoCyte will host a conference call and webcast today, Wednesday, May 18, 2016, at 5:00 p.m. ET/2:00 p.m. PT to discuss financial and operating results and recent corporate developments.

For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 877-524-8416. For international participants outside the U.S./Canada, the dial-in number is 412-902-1028. For all callers, refer to Conference ID 8993084. To access the live webcast, go to View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112; international callers dial 719-457-0820. Use the Conference ID 13634479. Additionally, the archived webcast will be available at View Source

On May 18, 2016 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported that data related to galeterone will be presented in two posters at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place from June 3-7, 2016, in Chicago (Press release, Tokai Pharmaceuticals, MAY 18, 2016, View Source;p=irol-newsArticle&ID=2169534 [SID:1234512555]). Galeterone, Tokai’s lead product candidate, is being developed for the treatment of men with metastatic castration-resistance prostate cancer.

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Title: Galeterone in treatment‐naïve patients with castration‐resistant prostate cancer with C‐terminal androgen receptor loss: Results from ARMOR2

Presenting author: Mary-Ellen Taplin, M.D., Associate Professor, Medicine, Harvard Medical School, and Chair, Executive Committee for Clinical Research, Dana-Farber Cancer Institute
Date/time: Saturday, June 4, 2016, 1 – 4:30 p.m. CDT
Location: Hall A
Abstract: 5064
Title: Randomized, open-label, multicenter, controlled study of galeterone vs enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC) expressing AR-V7 splice variant (ARMOR3-SV)

Presenting author: Emmanuel Antonarakis, M.D., Associate Professor of Oncology and Urology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Date/time: Saturday, June 4, 2016, 1 – 4:30 p.m. CDT
Location: Hall A
Abstract: TPS5085

A third abstract, "Galeterone targets proteasomal degradation of the androgen receptor in prostate tumor cells: A novel mechanism of action for treatment of AR-V7+ CRPC," was accepted for publication.

Additional information, including the presentation schedule and full abstracts, may be found at abstracts.asco.org. A copy of each presentation will be available on the "Publications & Presentations" page of Tokai’s website, www.tokaipharmaceuticals.com, after being presented at the meeting.

About Galeterone

Galeterone is an oral small molecule that utilizes the established pathways, including CYP17 enzyme and androgen receptor inhibition, of the current second-generation hormonal therapies abiraterone and enzalutamide. Galeterone also introduces a distinct third mechanism – androgen receptor degradation – that impairs the function of androgen receptors, decreasing their sensitivity to androgen activity and reducing tumor growth. Tokai is developing galeterone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). ARMOR3-SV, the company’s pivotal Phase 3 study of galeterone in treatment-naive mCRPC patients whose prostate tumors express the AR-V7 splice variant, is evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression-free survival as compared to enzalutamide. Tokai is also evaluating galeterone in mCRPC patients who have shown resistance following treatment with second-generation hormonal agents. Tokai has worldwide development and commercialization rights to galeterone.

On May 18, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) reported that it will present on its extensive oncology pipeline at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7, 2016 at McCormick Place, Chicago, Illinois (Press release, Merrimack, MAY 18, 2016, View Source [SID:1234512580]). Final results from a Phase 1 study evaluating the safety, pharmacology and initial efficacy of MM-151 will be presented in a Poster Discussion Session. Merrimack will also present on the results from its Phase 3 NAPOLI-1 study of ONIVYDE, as well as on multiple therapeutic candidates from its antibody engineering and antibody-directed nanotherapeutic (ADN) technology platforms in six poster sessions.

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Poster Discussion Session:

Final results of a first-in-human study evaluating the safety, pharmacology and initial efficacy of MM-151, an oligoclonal anti-EGFR antibody in patients with refractory solid tumors (Abstract 2518)
Session Title: Poster Discussion Session, Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Sunday, June 5, 2016, 11:30 AM – 12:45 PM CT
Location: Arie Crown Theater

Poster Sessions:

Updated overall survival (OS) analysis of NAPOLI-1: Phase 3 study of nanoliposmal irinotecan (nal-IRI, MM-398), with or without 5-fluorouracil and leucovorin (5-FU/LV), vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy (Abstract 4126)
Session Title: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

Randomized Phase 2 study of paclitaxel (PTX), trastuzumab (T) with or without MM-111 in HER2 expressing gastroesophageal cancers (GEC) (Abstract 4043)
Session Title: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

A Phase 1b/2 study combining MM-151 + nal-IRI + 5-FU + leucovorin in RAS-wild type metastatic colorectal cancer (mCRC) (Abstract TPS3633)
Session Title: Gastrointestinal (Colorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

SHERLOC: A Phase 2 study of seribantumab (MM-121) in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive (HRG+), locally advanced or metastatic non-small cell lung cancer (NSCLC) (Abstract TPS9110)
Session Title: Lung Cancer – Non-Small Cell Metastatic
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1) (Abstract TPS631)
Session Title: Breast Cancer – HER2/ER
Sunday, June 5, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

A Phase 1 biomarker-directed multi-arm study evaluating the co-administration of MM-151 with MM-121, MM-141, or trametinib in EGFR-driven cancers (Abstract TPS11619)
Session Title: Tumor Biology
Monday, June 6, 2016, 1:00 PM – 4:30 PM CT
Location: Hall A

On May 18, 2016 Eli Lilly reported that several studies will underscore the strength of Eli Lilly and Company’s (NYSE: LLY) diverse clinical cancer pipeline and portfolio during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, June 3 – 7, 2016 (Press release, Eli Lilly, MAY 18, 2016, View Source [SID:1234512520]). Presentations include new data on abemaciclib, a CDK 4 and 6 inhibitor, as well as: ramucirumab, a VEGF Receptor 2 antagonist; galunisertib, a TGFβ small-molecule kinase inhibitor; and emibetuzumab, a MET antibody.

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Other data to be presented at ASCO (Free ASCO Whitepaper) highlight Lilly’s ongoing immuno-oncology clinical collaborations with Merck (known as MSD outside the U.S. and Canada) in two trials that are evaluating ramucirumab and pemetrexed-plus-carboplatin, respectively, in combination with Merck’s pembrolizumab.

These presentations reflect Lilly’s multi-faceted strategy in developing cancer treatments – a balanced approach based on three scientific pillars of tumor cell growth and progression: cell signaling, tumor microenvironment and immuno-oncology. Lilly’s data at this year’s ASCO (Free ASCO Whitepaper) meeting highlight some of the recent progress it has made toward this strategy and touch on all three of these scientific pillars.

"The reality is that cancer is more than 200 diseases and the treatment of cancer needs to be aggressively approached from many angles," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "Our oncology R&D strategy is to produce a diverse portfolio of novel agents that attack tumor cell growth and progression in multiple ways to improve patient outcomes."

Dr. Gaynor continued, "We are encouraged by our data at ASCO (Free ASCO Whitepaper) and the progress of our pipeline toward achieving our overall goals. We’ve had notable clinical advancements with abemaciclib and olaratumab, both of which have been designated as breakthrough therapies by the FDA. These build on necitumumab and ramucirumab, which we are continuing to investigate in additional disease settings and combinations. Additionally, our immuno-oncology initiatives are increasingly producing results through collaborations and our own internal research efforts."

Select studies, along with the times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract #510: Oral Abstract Session: Friday, June 3, 2016; 4:42 – 4:54 pm CDT
MONARCH 1: Results from a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for advanced disease
Author/Speaker: Maura N. Dickler, M.D., Memorial Sloan Kettering Cancer Center
Location: Hall D1
Abstract #TPS9101: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A randomized phase 2 study of abemaciclib versus docetaxel in patients with stage IV squamous cell lung cancer (SqCLC) previously treated with platinum-based chemotherapy
Author/Speaker: Giorgio V. Scagliotti, M.D., Ph.D., University of Torino
Location: Hall A (Poster Board #423a)
Immuno-Oncology Collaborations with ramucirumab or pemetrexed

Abstract #3056: Developmental Therapeutics—Immunotherapy Poster Session: Sunday, June 5, 2016; 8:00 – 11:30 am CDT
A phase 1 study of ramucirumab (R) plus pembrolizumab (P) in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or urothelial carcinoma (UC): Phase 1a results
Author/Speaker: Roy S. Herbst, M.D., Ph.D., Yale University School of Medicine, Yale Cancer Center
Location: Hall A (Poster Board #378)
Abstract #9016: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
Pembrolizumab (pembro) plus chemotherapy as front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C
Author/Speaker: Shirish M. Gadgeel, M.D., Karmanos Cancer Institute
Location: Hall A (Poster Board #339)
Poster Discussion Session: Saturday, June 4, 2016; 3:00 – 4:15 pm CDT Room E354b
Ramucirumab

Abstract #TPS4145: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A randomized, double-blind, placebo-controlled Phase III study of ramucirumab versus placebo as second-line treatment in patients with hepatocellular carcinoma and elevated baseline alpha-fetoprotein following first-line sorafenib (REACH-2)
Author/Speaker: Andrew X. Zhu, M.D., Ph.D., Massachusetts General Hospital Cancer Center
Location: Hall A (Poster Board #130a)
Abstract #9079: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
Exploratory subgroup analysis of patients (Pts) refractory to first-line (1L) chemotherapy from REVEL, a randomized phase III study of docetaxel (DOC) with ramucirumab (RAM) or placebo (PBO) for second-line (2L) treatment of stage IV non-small-cell lung cancer (NSCLC)
Author/Speaker: Martin Reck, M.D., Ph.D., Lungen Clinic Grosshansdorf, Airway Research Center North
Location: Hall A (Poster Board #402)
Galunisertib

Abstract #4070: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A phase 2 study of galunisertib, a novel transforming growth factor-beta (TGF-β) receptor I kinase inhibitor, in patients with advanced hepatocellular carcinoma (HCC) and low serum alpha fetoprotein (AFP)
Author/Speaker: Sandrine J. Faivre, M.D., Ph.D., Service d’Oncologie Médicale
Location: Hall A (Poster Board #62)
Abstract #4019: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A phase II, double-blind study of galunisertib+gemcitabine (GG) vs gemcitabine+placebo (GP) in patients (pts) with unresectable pancreatic cancer (PC)
Author/Speaker: Davide Melisi, M.D., University of Verona
Location: Hall A (Poster Board #11)
Poster Discussion Session: Saturday, June 4, 2016; 3:00 – 4:15 pm CDT at Hall D1
Emibetuzumab

Abstract #9070: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A randomized, open-label, phase 2 study of emibetuzumab plus erlotinib (LY+E) and emibetuzumab monotherapy (LY) in patients with acquired resistance to erlotinib and MET diagnostic positive (MET Dx+) metastatic NSCLC
Author/Speaker: D. Ross Camidge, M.D., Ph.D., University of Colorado
Location: Hall A (Poster Board #393)