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SEPTEMBER 2018    A Monthly Review of Articles of Interest for the Clinical Community

..This Month's Clinical Focus:  HEMATOLOGY..

 

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FDA approves new kind of treatment for hairy cell leukemia


The FDA has approved Lumoxiti a CD22-directed cytotoxin - the first of this type of treatment for patients with HCL

 

FDA Logo-2The U.S. Food and Drug Administration approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.

HCL is a rare, slow-growing cancer of the blood in which the bone marrow makes too many B cells (lymphocytes), a type of white blood cell that fights infection. HCL is named after these extra B cells which look "hairy" when viewed under a microscope. As the number of leukemia cells increases, fewer healthy white blood cells, red blood cells and platelets are produced.

"Lumoxiti fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "This therapy is the result of important research conducted by the National Cancer Institute that led to the development and clinical trials of this new type of treatment for patients with this rare blood cancer."

The efficacy of Lumoxiti was studied in a single-arm, open-label clinical trial of 80 patients who had received prior treatment for HCL with at least two systemic therapies, including a purine nucleoside analog. The trial measured durable complete response (CR), defined as maintenance of hematologic remission for more than 180 days after achievement of CR. Thirty percent of patients in the trial achieved durable CR, and the overall response rate (number of patients with partial or complete response to therapy) was 75 percent.

The FDA granted the approval of Lumoxiti to AstraZeneca Pharmaceuticals. and granted this application Fast Track and Priority Review designations. Lumoxiti also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.


SOURCE: Used by Permission of PRNewswire


Predictive Clinical Biomarker Approach to Identify Acute Myeloid Leukemia (AML) Patients Most Likely to Respond to Onvansertib

 

Target engagement and inhibition of PLK1 by Onvansertib predictive of treatment response

 

Trovagene, Inc., using a precision medicine approach to develop drugs for the treatment of leukemias, lymphomas and solid tumor cancers, announced it has developed a method for predicting response to treatment by measuring the ability of Onvansertib, a first-in-class, 3rd generation, oral and highly-selective Polo-like Kinase 1 (PLK1 ) inhibitor, to inhibit PLK1 in patients with Acute Myeloid Leukemia (AML).

 

PLK1 uniquely phosphorylates translational control tumor protein (TCTP) to form pTCTP and inhibition of this enzymatic activity by Onvansertib appears to be predictive of patient response to treatment. In the ongoing Phase 1b/2 open label clinical trial in AML, PLK1 inhibition is being assessed 3-hours following administration, at the approximate peak concentration (Cmax) of Onvansertib. In the first six patients treated, the greatest target engagement, or inhibition of PLK1, was observed in the three patients who showed a response to treatment.
 

Drug Dev System Gears


"We are encouraged by these preliminary results and believe that a simple blood test obtained 3-hours post-dose could enrich for patients who are most likely respond to treatment with Onvansertib," said Dr. Mark Erlander, Chief Scientific Officer of Trovagene.  "We believe that integrating a predictive biomarker strategy into our Onvansertib clinical development program may enable us to tailor treatment to specific sub-groups of patients and have a positive clinical impact."

Trovagene has filed a U.S. patent application with the United States Patent and Trademark Office (USPTO) to protect its method for evaluating responsiveness of a cancer to a Polo-like Kinase 1 (PLK1) inhibitor by determining the ability of the PLK1 inhibitor to inhibit phosphorylation of a unique target of PLK1 in cells of the cancer.

About the Onvansertib Phase 1b/2 Acute Myeloid Leukemia Trial
The Phase 1b/2 trial (NCT03303339) is a multi-center, open-label trial to evaluate the safety and efficacy of Onvansertib in combination with standard-of-care chemotherapy in AML patients who are ineligible for intensive induction therapy or whose disease is relapsed or refractory. In Phase 1b dose-escalation segment of the trial, the primary objective is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), using a traditional 3+3 design. In Phase 2 the MTD or RP2D will be administered to 32 patients to evaluate preliminary antitumor activity and to continue to evaluate the safety and tolerability of Onvansertib in combination with standard-of-care chemotherapy. (A Phase 1 open-label, dose escalation safety study of Onvansertib has been completed in patients with advanced metastatic solid tumor cancers and published in Investigational New Drugs)

 

SOURCE: Used by Permission of PRNewswire


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