Novel Entrectinib Trial Focuses on Gene Rearrangements Across Many Tumor Types

Excerpt:

“A decade ago, researchers believed molecular alterations occurred in only one or two cancer types. That way of thinking has changed, however, with the understanding that the same alterations, especially gene fusions, can occur across many different tumor types.

“As a result, researchers have designed a recently launched clinical study into entrectinib, a first-inclass inhibitor of tropomyosin receptor kinases (Trk), as a basket trial in which the drug can be evaluated simultaneously for activity against three gene alterations and multiple tumor types.

“STARTRK-2 (NCT02568267) is an open-label, phase II study in which patients with locally advanced or metastatic solid tumors are assigned to different baskets according to whether their tumors harbor rearrangements in one of three key genes—NTRK1/2/3, ROS1, or ALK.”

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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.”


AbbVie Initiates Veliparib Phase III Trial in BRCA-mutated Advanced Breast Cancer Patients

“AbbVie has initiated its Phase III trial investigating the safety and efficacy of the investigational PARP inhibitor veliparib in combination with carboplatin and paclitaxel in advanced breast cancer patients.

“In the double-blind study, researchers will randomize nearly 300 patients to receive either veliparib, plus the carboplatin/paclitaxel combination, or just the chemotherapy regimen. Metastatic or locally advanced breast cancer patients enrolled in the trial will have to have tumors that are HER2 negative, but positive for BRCA1/2 mutations. AbbVie is working with Myriad Genetics to use its BRACAnalysis test to gauge BRCA mutations in study subjects.

“Researchers will assess in the study whether adding veliparib significantly increases patients’ progression-free survival compared to treatment with only chemotherapy. Other endpoints in the study are overall survival, clinical benefit rate, objective response rate, and duration of response.”

Editor’s note: Clinical trials are research studies that test new treatments on volunteer patients. In many clinical trials, some patients receive the new drug being tested, and for comparison, some patients receive “standard of care” treatment, meaning a U.S. Food and Drug Administration (FDA)-approved treatment that their oncologists would likely have considered for them. This story discusses a new clinical trial that is testing a drug called veliparib. The trial is enrolling people with advanced breast cancer who are HER2 negative and have BRCA1/2 mutations. Some of the patients will be treated with standard chemotherapy (a combination of the drugs carboplatin and paclitaxel), and some will receive veliparib PLUS standard chemotherapy. The trial is randomized, meaning patients will not get to choose which of the two treatments they receive. The goal of the clinical trial is to figure out whether adding veliparib to the chemo improves outcomes for patients.


Super Patient: Chelsea Price Takes Charge of Stage III Melanoma


Late in 2010, Chelsea Price’s boyfriend noticed that a mole on her upper back was scabbed and weeping. “It had always been there but he thought I should get it checked,” recalls Chelsea, who was then 23 years old. By the time her dermatology appointment rolled around, however, the mole had healed. “I almost cancelled,” she says.

Good thing she didn’t. At her follow-up appointment, her dermatologist casually said, “Hey, it’s melanoma.” Thinking he was kidding, Chelsea started laughing. When she realized he was serious, she was stunned. Continue reading…