MEK Inhibitor Disappoints in KRAS-Mutant NSCLC

Excerpt:

“A targeted combination therapy for patients with KRAS-mutant non-small cell lung cancer (NSCLC) did not improve overall survival (OS) or progression-free survival (PFS), researchers reported.

“The phase III, randomized SELECT-1 trial compared the experimental MEK inhibitor selumetinib, in combination with docetaxel (Taxotere), with docetaxel and placebo as second-line therapy in patients who failed a previous line of therapy, explained Pasi Jänne, MD, PhD, of the Dana Farber Cancer Institute in Boston, and colleagues.

“After a follow-up of approximately 1 year, median OS in the selumetinib combination group was 8.7 months versus 7.9 months in the docetaxel plus placebo group (hazard ratio 1.05, 95% CI 0.85-1.30, P=0.64), they wrote in JAMA.

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Scientists Find Lethal Vulnerability in Treatment-Resistant Lung Cancer

Excerpt:

“Researchers working in four labs at UT Southwestern Medical Center have found a chink in a so-called ‘undruggable’ lung cancer’s armor — and located an existing drug that might provide a treatment.

“The study, published this week in Nature, describes how the drug Selinexor (KPT-330) killed lung cancer cells and shrank tumors in mice when used against cancers driven by the aggressive and difficult-to-treat KRAS cancer gene. Selinexor is already in clinical trials for treatment of other types of cancer, primarily leukemia and lymphoma but also gynecological, brain, prostate, and head and neck cancers.”

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AstraZeneca Provides Update on Phase III Trial of Selumetinib in Non-Small Cell Lung Cancer

Excerpt:

“AstraZeneca today announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC).

“The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.”

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Targeted Therapies Beneficial in KRAS-Mutated NSCLC

Excerpt:

“Targeted therapies that do not contain erlotinib can be beneficial for patients with KRAS-mutated (KRAS mut+) advanced non-small-cell lung cancer (NSCLC), according to a study published online Aug. 1 in the Journal of Clinical Oncology.

“Vassiliki Papadimitrakopoulou, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues examined the effects of targeted therapies in NSCLC. Patients were randomized to four arms: erlotinib (22 patients), erlotinib plus MK-2206 (42 patients), MK-2206 plus AZD6244 (75 patients), or sorafenib (61 patients).

“The researchers found that the primary end point of an eight-week disease control rate (DCR) was 48 percent in all 186 evaluable patients (32, 50, 53, and 46 percent, respectively, for the four treatment arms). For the 27 percent of patients who were KRAS mut+, DCR was 20, 25, 62, and 44 percent, respectively, compared with 36, 57, 49, and 47 percent, respectively, for KRAS wild-type patients. Median progression-free survival was 2.0 months: 1.8 and 2.5 months for arms 1/2 and 3/4, respectively, in KRAS mut+ patients (P = 0.04). In KRAS wild-type patients, median overall survival was 6.5 months: 9.0 and 5.1 months in arms 1/2 and 3/4, respectively (P = 0.03).”

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Possible Treatment on Horizon for Advanced KRAS-Mutant NSCLC

Excerpt:

“Promising early phase clinical trials have led to the initiation of the phase III JUNIPER trial, which is assessing abemaciclib (LY2835219) for patients with previously treated KRAS-mutant lung cancer, a traditionally hard to treat genetic subtype.

“JUNIPER is an open label phase III study currently recruiting patients with stage IV non–small cell lung cancer (NSCLC) with a detectable KRAS mutation who have progressed following treatment with platinum-based chemotherapy (NCT02152631). Patients will be randomized to receive either abemaciclib or erlotinib, both with best supportive care.

“ ‘KRAS mutations are common in patients with NSCLC, but there have been few clinical advances in our treatment for these patients,’ said investigator Jonathan W. Goldman, MD, of the Department of Medicine, Hematology/Oncology, member of the Signal Transduction and Therapeutics Program Area at UCLA’s Jonsson Comprehensive Cancer Center, who explored the drug in a phase I trial.”

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BIND-014 Being Tested as Treatment for Advanced/Metastatic NSCLC That's Squamous or KRAS+

The gist: The first patient has been enrolled in a clinical trial testing the drug BIND-014 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that is squamous or has a mutation in the KRAS gene. An earlier clinical trial found promising results for these patients. BIND-014 is a new form of the chemotherapy drug docetaxel. It is meant to home in on cancer cells to deliver chemotherapy directly.

“BIND Therapeutics, Inc. (BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins™, today announced its 2015 strategic overview and enrollment of the first patient expressing a KRAS mutation in a global, multicenter two-tiered phase 2 trial with BIND-014 in non-small cell lung cancer (NSCLC) patients with KRAS mutant tumors (mutated Kirsten ras oncogene homolog) or squamous histology. The trial was driven by positive results from the phase 2 trial in NSCLC presented at the EORTC-NCI-AACR Annual Symposium in Barcelona on November 19, 2014, with a confirmed objective response rate of 22 percent (n=9); one KRAS mutant NSCLC PR was also seen in the phase 1 trial with BIND-014, yielding a combined total response rate of 30 percent (n=10). Results from the phase 2 trial also suggested meaningful differentiation in NSCLC patients with squamous histology when compared to historical docetaxel results. BIND-014 results presented at EORTC-NCI-AACR also demonstrated a disease control rate of 66 percent and overall survival of 11.1 months (n=9) in NSCLC patients with squamous histology. BIND intends to begin accruing NSCLC patients with squamous cell histology in the two-tier phase 2 trial in 1Q 2015.”