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AUGUST 2017    A Monthly Review of Articles of Interest for the Clinical Community

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<This Month's Clinical Focus:>

<HEMATOLOGY>


Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AML


FDA Approval of Jazz Pharmaceuticals' Vyxeos™ (daunorubicin and cytarabine) Liposome for Injection for the Treatment of Adults with Newly-Diagnosed Therapy-Related Acute Myeloid Leukemia (t-AML) or AML with Myelodysplasia-Related Changes (AML-MRC)

 

"Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.  "The FDA approval of Vyxeos reflects our commitment to addressing unmet needs within the hematology oncology community."

blood-1813410_1920 by qimono at Pixabay FREE LIC CC0


TRIAL SUMMARY   The FDA approval is based on data from a pivotal Phase 3 clinical trial that evaluated the efficacy and safety of Vyxeos compared to cytarabine and daunorubicin (7+3) in 309 patients 60 to 75 years of age with newly diagnosed t-AML or AML-MRC.  In the Vyxeos arm, patients received 44mg/100mg per m2 (daunorubicin and cytarabine) liposome intravenously via a 90 minute infusion on days 1, 3 and 5 of induction (days 1 and 3 if a second induction was needed) and 29mg/65mg per m2 (daunorubicin and cytarabine) liposome on days 1 and 3 for consolidation.  Patients in the 7+3 arm received induction with cytarabine 100mg/m2/day on days 1-7 by continuous infusion and daunorubicin 60mg/m2/day on days 1-3.  For consolidation, cytarabine was dosed on days 1-5 and daunorubicin on days 1-2.  For the primary endpoint of overall survival, Vyxeos demonstrated an improvement that was superior to the 7+3 treatment regimen.  The median overall survival for the Vyxeos treatment group was 9.6 months compared with 5.9 months for the 7+3 treatment group (p = 0.005; HR = 0.69 [0.52, 0.90]).  Vyxeos also demonstrated a statistically significant improvement in complete response rate of 38 percent versus 26 percent; p=0.036.  The overall, all-cause 30-day mortality was 6 percent in the Vyxeos arm and 11 percent in the control arm. Six percent of patients in both the Vyxeos and control arm had a fatal adverse reaction on treatment or within 30 days of therapy that was not in the setting of progressive disease.  During the first 60 days of the study, 14 percent of patients died in the Vyxeos arm versus 21 percent of patients in the 7+3 arm.  In addition, the overall rate of hematopoietic stem cell transplant (HSCT) was 34 percent in the Vyxeos arm and 25 percent in the 7+3 arm.  In the Phase 3 study, the most common adverse reactions (incidence = 25%) were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders and vomiting.   

Designed with Jazz's CombiPlex® proprietary technology, Vyxeos is a unique liposomal formulation that delivers a fixed-ratio of daunorubicin and cytarabine to the bone marrow that has been shown to have synergistic effects at killing leukemia cells in vitro and in animal models.  Vyxeos is the first product developed with the company's proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies. Vyxeos improved overall survival compared to standard of care 7+3 (cytarabine and daunorubicin) regimen (9.6 months vs. 5.9 months, respectively). 

"Vyxeos is the first chemotherapy to demonstrate an overall survival advantage over the standard of care in a Phase 3 randomized study of older adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Jeffrey E. Lancet, MD, Chair of the Department of Malignant Hematology at Moffitt Cancer Center.  "The prognosis for these patients is poor, so the FDA approval of this new drug provides a welcome therapeutic advance."


Displayed with permission from PR Newswire


ONIVYDE® Receives Approval in Canada for the Treatment of Metastatic Adenocarcinoma of the Pancreas in the Post-Gemcitabine Setting 

 

ONIVYDE (Shire Canada) is the first and only treatment shown to increase median overall survival by up to two months for adult pancreatic cancer patients who have disease progression following gemcitabine-based therapy

ONIVYDE (irinotecan liposome for injection) has been approved for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have disease progression following gemcitabine-based therapy.3 ONIVYDE is the first and only approved treatment option for this patient population who have no universally accepted standard of treatment until now. Based on the NAPOLI-1 trial, ONIVYDE has been shown to extend patients' overall survival by two additional months.

With the pancreas so deep in the abdomen, about 60 per cent of pancreatic cancers are detected at a late stage, which significantly contributes to its poor prognosis.  While first-line treatments are available to patients, disease progression after initial therapy is common, leaving patients with no options for further treatment.

 

Ultrasound_image_of_pancreas_110328111508_1115360 FREE LIC NIH


ONIVYDE was evaluated in NAPOLI-1, the first global, phase III trial to demonstrate a positive outcome in patients with disease progression following gemcitabine-based therapy.12 Patients who received ONIVYDE in combination with 5-FU/LV saw significant improvements in median overall survival (45 per cent increase), progression-free survival (100 per cent increase) and objective response rate (16.2 per cent) relative to those who received 5-FU/LV alone (0.8 per cent).

"There have been very few treatment advancements for metastatic pancreatic cancer over the years.  Until now, when patients failed on their first line drug, they would be left without any good options," says Dr. Jeff Rothenstein, medical oncologist at the R.S. McLaughlin Durham Regional Cancer Center in Oshawa. "The approval of ONIVYDE means pancreatic cancer patients have another treatment option that could help them continue their fight against the disease."

"Treating pancreatic cancer is challenging, especially given the disease's vague symptoms which are often mistaken for benign conditions. This frequent misdiagnosis means many patients are diagnosed with pancreatic cancer at a late stage," says Stefanie Condon-Oldreive, Founder and Director of Craig's Cause Pancreatic Cancer Society. "This new treatment is exciting news because it means patients have a new option to turn to, one that could improve their quality of life and provide them with meaningful time with those they love. For pancreatic cancer patients, that time is of the utmost importance."


Displayed with permission from PR Newswire


Image credits: Blood Cells Photo courtesy © Nevit Dilmen [CC BY-SA 3.0 via Wikimedia Commons]; Ultrasound of Pancreas courtesy of NIH Public Images

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