Massive Bio Aims to Improve Clinical Trial Enrollment Rates With Oncology Registry, Matching Tool

Excerpt:

“Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.

“Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.”

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Why Can’t Dying Patients Get the Drugs They Want?

Excerpt:

“At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.

“Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.

“But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”

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CMS Starts to Cover Broad Cancer DNA Tests, Boosting Foundation, Thermo

Excerpt:

“The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations. The news is a boost for companies like Foundation Medicine and Thermo Fisher Scientific, who are among the few firms with such tests on the market.

“Late Friday, the CMS said that, going forward, it will start to reimburse for tests that use DNA sequencing technology to map the tumors of patients with advanced cancers once approved by the FDA. Two of the already-approved tests fitting this description are FoundationOne CDx, from Cambridge, MA-based Foundation, and Oncomine Dx Target Test, from Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO). FoundationOne CDx looks for 324 cancer-related alterations in patients’ DNA. Foundation amasses a report based on the results and sends it to doctors, who use the data to suggest possible treatments. Oncomine detects 23 genetic alterations associated with non-small cell lung cancer.”

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Cabozantinib Active in Carcinoid Tumors and Pancreatic NETs

Excerpt:

“Cabozantinib (Cabometyx) demonstrated promising clinical activity in patients with carcinoid tumors and pancreatic neuroendocrine tumors (NETs) in a phase II trial.

“Patients with advanced carcinoid tumors (n = 41) or pancreatic NETs (n = 20) were enrolled in parallel cohorts. Both groups received 60 mg of oral cabozantinib daily and were restaged every 2 months for the first 6 months, and then every 3 months.”

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Kulke Sheds Light on Emerging Agents for Neuroendocrine Tumors

Excerpt:

“Several emerging agents are rapidly advancing the treatment paradigm for patients with neuroendocrine tumors (NETs).

“Lutathera (lutetium Lu 177 dotate) was approved by the FDA in January 2018 for patients with somatostatin receptor–positive gastroenteropancreatic NETs. The approval follows the findings of the phase III NETTER-1 trial, which demonstrated a 79% reduction in the risk of progression or death with Lutathera compared with octreotide LAR.”

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FDA Approves New Treatment for Certain Digestive Tract Cancers

Excerpt:

“The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.”

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New Guidelines on Clinical Trial Design for Patients with Brain Metastases

Excerpt:

“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”

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Cancer Clinical Trials Exclude Many Desperate Patients. Should That Change?

Excerpt:

“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.

“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”

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Chemotherapy Drug Maintains Quality of Life Despite Side Effects

Excerpt:

“Patients with advanced neuroendocrine tumors (NETs) reported similar health-related quality of life (HRQOL) during treatment with a recently approved chemotherapy drug as compared to patients receiving a placebo treatment, according to a clinical trial published in Lancet Oncology.

“These findings, in conjunction with previous research showing delayed disease progression, suggest the drug, called everolimus, may be able to preserve quality of life even in light of chemotherapy’s often-toxic side effects. The findings support the usefulness of HRQOL as an endpoint in clinical trials studying NETs, in a secondary analysis of their findings, according to the study.”

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