publication date: Jan. 8, 2016

Breakthrough Therapy Granted to Boehringer Ingelheim Inhibitor in NSCLC 


FDA granted Breakthrough Therapy Designation to an epidermal growth factor receptor mutant-specific tyrosine kinase inhibitor, BI 1482694 (HM61713).

The designation is based on results from the phase I/II HM-EMSI-101 clinical trial evaluating the treatment of T790M mutation-positive non-small cell lung cancer in patients whose tumors have stopped responding to currently available EGFR-directed therapies. These data were presented at the ESMO Asia 2015 Congress in Singapore and ASCO 2015 in Chicago.

BI 1482694 is an oral, third-generation EGFR mutant-selective TKI developed to specifically target tumors with T790M mutations. The T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs, according to the drug’s sponsor, Boehringer Ingelheim.

In patients with T790M-positive NSCLC who had previously been treated with an EGFR TKI, objective responses (ORs) by independent assessment were observed in 62 percent patients, including 32 (46 percent) patients whose tumor response had been confirmed at the time of data cut-off. Disease control rate was 91 percent by independent assessment. At the time of data cut off, median duration of response had not yet been reached and will be reported at a later date.

The most common treatment-related adverse events included diarrhea, nausea, rash and skin itching.

A global phase II trial, ELUXA 1, has been initiated to evaluate the efficacy and safety of BI 1482694 in patients with T790M mutation-positive NSCLC whose tumors stopped responding to currently available EGFR directed therapies. The primary endpoint of this trial, which is the first in a broad clinical development program for BI 1482694, is objective response rate.


MD Anderson Cancer Center and Kymab announced a partnership in immuno-oncology research.

The program will be conducted with MD Anderson’s Oncology Research for Biologics and Immunotherapy Translation unit. The partnership will focus on developing novel human therapeutic antibodies to treat a variety of cancers using Kymab’s Kymouse antibody discovery platform. The agreement is for an initial period of five years.

The ORBIT platform is a centralized organization within MD Anderson, which focuses on translating discoveries into clinically relevant anti-cancer mAbs. ORBIT’s scientific directors are Jeffrey Molldrem, professor of the Department of Stem Cell Transplantation and Cellular Therapy, and Michael Curran, professor of the Department of Immunology.


Guardant Health and Mirati Therapeutics Inc. entered into a collaboration for the development of a circulating tumor DNA assay for Mirati’s kinase inhibitor, glesatinib.

Guardant360 is a blood test that identifies multiple tumor mutations across all four types of genomic alterations: single nucleotide variations, copy number amplifications, indels, and fusions. As part of the collaboration with Mirati, Guardant360 will be used to screen NSCLC patients for certain genetic alterations to the MET pathway in order to identify the patients most likely to respond to glesatinib.

The assay will sequence for patients with certain MET mutations and MET gene amplification. This plasma-based assay offers a less invasive approach to assess tumor genetics, avoiding tumor biopsies.

The collaboration will use Guardant360 in Mirati’s phase II clinical trial of glesatinib in patients with NSCLC. If successful, the collaboration could result in a regulatory submission and approval of the Guardant360 platform as a companion diagnostic for glesatinib.

“Identifying patients with MET mutations or MET gene amplification is the key to our patient selection strategy. Clinical data has shown that these are the patients most likely to respond to glesatinib,” said Charles Baum, president and CEO of Mirati.

“Collaborating with Guardant on a ctDNA assay means that we expect to be able to detect these mutations in a blood sample. This will enable the more than 30 percent of non-small cell lung cancer patients, who have insufficient tumor tissue for biopsy, to be screened for genetic alterations that may be driving their cancer and to seek treatment that could lead to improved outcomes.”


Eli Lilly and Co. and Halozyme Therapeutics Inc. entered into a global collaboration and license agreement to develop and commercialize products combining proprietary Lilly compounds with Halozyme’s Enhanze platform.

Under the terms of the agreement, Halozyme will receive an initial $25 million payment, followed by milestone payments of up to $160 million for each of up to five collaboration targets valued at up to $800 million. These payments are subject to Lilly’s achievement of specified development, regulatory and sales-based milestones. In addition, Lilly will pay Halozyme royalties if products under the collaboration are commercialized.

The Halozyme Enhanze platform is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan, a chain of natural sugars, to aid in the dispersion and absorption of other injected therapeutic drugs.

Merck signed a collaboration agreement with Biocartis for the development and commercialization of a new liquid biopsy RAS biomarker test for patients with metastatic colorectal cancer.

The test will be developed on Biocartis’ automated molecular diagnostics system Idylla. The new test aims to support clinical practice in performing integrated liquid biopsy RAS biomarker tests, independently of the laboratories’ volume of testing or level of expertise.

“Through this collaboration, our desire is to have more metastatic colorectal cancer patients gain access to liquid biopsy RAS testing, regardless of their geographical location,” said Rehan Verjee, chief marketing and strategy officer of Merck’s biopharma business. “The Biocartis technology will be complementary to other technology previously developed, and will allow for liquid biopsy RAS offerings to a wide range of lab segments, regardless of size and expertise levels.”

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