Chi-Med Presented Sulfatinib Neuroendocrine Tumors Phase Ib/II Results at the 14th Annual Conference of European Neuroendocrine Tumor Society

Excerpt:

“Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) presented data from the ongoing Phase Ib/II clinical trial of sulfatinib in patients with advanced neuroendocrine tumors (“NET”) at the 14th Annual Conference of European Neuroendocrine Tumor Society (“ENETS”), held in Barcelona, Spain from March 8 to 10, 2017. Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively targets vascular endothelial growth factor receptor (“VEGFR”), fibroblast growth factor receptor (“FGFR”) and colony-stimulating factor-1 receptor (“CSF-1R”), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Five other sulfatinib clinical trials are underway in China and the US, including two Phase III studies in NET patients (SANET-p and SANET-ep), one Phase II study in thyroid cancer patients and one Phase II study in biliary tract cancer patients.”

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FGFR Inhibitor Dovitinib Shows Modest Efficacy in Squamous NSCLC

Excerpt:

“The FGFR inhibitor dovitinib showed modest efficacy in a phase II trial of patients with pretreated, advanced squamous cell carcinoma (SCC) of the lung with FGFR1 amplification. Further work on the drug, in particular to find biomarkers of efficacy, was deemed warranted.

“ ‘The majority of new cytotoxic chemotherapies for the treatment of non–small-cell lung cancer (NSCLC) such as pemetrexed or targeted agents such as gefitinib or erlotinib are not indicated for the SCC subtype because of a lack of efficacy or because activity is limited to tumors with specific genetic alterations that are rarely found in patients with squamous cell NSCLC,’ wrote study authors led by Myung-Ju Ahn, MD, PhD, of Samsung Medical Center in Seoul, South Korea. SCC accounts for about 30% of all NSCLC cases.”

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Investigational Compound Targets FGFR Pathway

“A novel selective inhibitor of the FGFR pathway yielded a 33% response rate in a small cohort of patients with gastroesophageal cancer, according to findings presented at the ASCO Annual Meeting.

“Elizabeth Catherine Smyth, MD, clinical research fellow in the gastrointestinal and lymphoma department at The Royal Marsdenin London, and colleagues investigated AZD4547 (AstraZeneca) — a selective inhibitor of FGFR 1, 2 and 3 receptor tyrosine kinases — in patients with FGFR1/2-amplified cancers.

“ ‘The FGFR signaling pathway plays a key role in oncogenesis,’ Smyth said during the presentation. ‘The nature and frequency of FGFR pathway abnormalities varies frequently between tumor types. The focus of this study is on FGFR-amplified tumors.’

“Smyth and colleagues screened 285 patients with advanced cancer and identified FGFR1 amplification in 18% (n = 20 of 111) of patients with HER-2–negative breast cancer and 9.5% (n = 4 of 42) of patients with non–small cell lung cancer, as well as FGFR2 amplification in 7.6% (n = 10 of 132) of patients with gastroesophageal cancer.”


FGFR-Targeted Therapy Demonstrated Activity in Solid Tumors

“Patients with solid tumors with fibroblast growth receptor genetic alterations demonstrated tumor shrinkage with the novel agent BGJ398, according to study results presented at the American Association for Cancer Research Annual Meeting.

“The benefit was particularly apparent among patients with FGFR3-mutated urothelial cancer.

“ ‘An emerging concept in cancer treatment is to try to treat cancers with a genetically defined alteration with an inhibitor of the receptor tyrosine kinase that drives the cancer growth,’ Lecia V. Sequist, MD, MPH, associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, said during a press conference. ‘This clinical study enrolled patients with many different tumor types. There are many types of tumors that have alterations of FGFR. Importantly, in contrast to other, more promiscuous multitargeted kinase inhibitors that happen to inhibit FGFR as one of their targets, BGJ398 has really no significant inhibition of the VEGF family of receptors.’ ”

Editor’s note: This clinical trial testing a new targeted therapy drug called BGJ398 found that it can shrink tumors that have mutations in the FGFR gene, as detected by molecular testing.


Squamous Lung Cancer ‘Master Protocol’ Brings Cancer Research into the 21st Century


Clinical trials help determine whether new cancer treatments are safe and effective, and they provide access to cutting-edge drugs that patients wouldn’t otherwise be able to have. But the clinical trial system is notoriously inefficient, slow, expensive, and laborious. Now, a new and ambitious clinical trial design called the Lung Cancer Master Protocol seeks to overhaul the system, promising to benefit patients and drug companies alike. Continue reading…


Novartis Revolutionizes Clinical Trials for Targeted Cancer Drugs


Someone had to do it; now it looks like Novartis may be the first. The pharma company’s new series of clinical trials, SIGNATURE (also known as, ‘bring the protocol to the patient,’ or  ‘P2P’), is recruiting patients with different cancers to receive investigational targeted drugs selected to match the distinct genetic changes found in each patient’s tumor. Continue reading…


Inhibitor-Sensitive FGFR2 and FGFR3 Mutations in Lung Squamous Cell Carcinoma

In lung squamous cell carcinoma (lung SCC), one of the most frequently altered receptor tyrosine kinase families is the fibroblast growth factor receptor (FGFR) family, with amplification or mutation observed in all four family members. Here, we describe the oncogenic nature of mutations observed in FGFR2 and FGFR3. We show that several of these mutations drive cellular transformation. Transformation can be reversed by small-molecule FGFR inhibitors currently being developed for clinical use.


Identification of Targetable FGFR Gene Fusions in Diverse Cancers

“Through a prospective clinical sequencing program for advanced cancers, four index cases were identified which harbor gene rearrangements of FGFR2 including patients with cholangiocarcinoma, breast cancer, and prostate cancer. After extending our assessment of FGFR rearrangements across multiple tumor cohorts, we identified additional FGFR gene fusions with intact kinase domains in lung squamous cell cancer, bladder cancer, thyroid cancer, oral cancer, glioblastoma, and head and neck squamous cell cancer. All FGFR fusion partners tested exhibit oligomerization capability, suggesting a shared mode of kinase activation.”


Identification of Targetable FGFR Gene Fusions in Diverse Cancers

“Through a prospective clinical sequencing program for advanced cancers, four index cases were identified which harbor gene rearrangements of FGFR2 including patients with cholangiocarcinoma, breast cancer, and prostate cancer. After extending our assessment of FGFR rearrangements across multiple tumor cohorts, we identified additional FGFR gene fusions with intact kinase domains in lung squamous cell cancer, bladder cancer, thyroid cancer, oral cancer, glioblastoma, and head and neck squamous cell cancer. All FGFR fusion partners tested exhibit oligomerization capability, suggesting a shared mode of kinase activation.”