ASH Clinical News July 2016 | Page 25

CLINICAL NEWS

Beginning in January 2018 , the American Board of Internal Medicine ( ABIM ) will offer physicians a new Maintenance of Certification ( MOC ) assessment option . Participating physicians will be able to choose an MOC assessment format that better meets their needs . The new assessment option will :

• Include shorter assessments that doctors can choose to take on their personal or office computer ( with appropriate identity verification and security ) more frequently than every 10 years , but no more than annually

• Provide feedback on important knowledge gap areas so physicians can better plan their learning to stay current in knowledge and practice

• Allow physicians who engage in and perform well on these shorter assessments to test out of the current assessment taken every 10 years

Physicians who meet a performance standard on shorter assessments will not need to take the 10-year exam again to remain certified , the ABIM noted in a news release . Physicians with certifications that expire before the new assessment option is offered in their specialty will still need to take and pass the current exam to maintain their certification . ABIM ’ s current 10-year exam will remain available as a second assessment option , and both options will reflect input ABIM solicited from physicians and other stakeholders as well as the recommendations from its Assessment 2020 Task Force .

“ By offering shorter assessments that they could take at home or at the office , we hope to lower the stress and burden that many physicians have told us the current 10-year exam generates ,” ABIM President and CEO Richard J . Baron , MD , said in the news release .

This new option will initially be available only for physicians maintaining certification in internal medicine , and possibly one or two subspecialties still to be determined .

“ ASH is pleased that the ABIM is responding to concern about the MOC as expressed by many hematologists ,”

ASH President Charles S . Abrams , MD , said in a statement , adding that changes to the MOC program are long overdue . “ Hematologists uniformly note that any single exam or assessment does not recognize the diversification of career paths in the subspecialty .”

Overall , he expressed that “ ASH is pleased with this new development and has already urged the ABIM to prioritize hematology in its roll-out of the new assessment option .”

There will be a public comment period about the potential changes before the new assessment option is implemented , and ABIM is expected to provide more specific details about the alternative assessment option no later than December 31 , 2016 .

Sources : ABIM news release , May 5 , 2016 ; ASH press release , May 6 , 2016 .

The U . S . Food and Drug Administration ( FDA ) granted priority review to blinatumomab for the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative ( Ph− ) relapsed / refractory B-cell precursor acute lymphocytic leukemia ( ALL ).

The decision was based on the results from a single-arm , multi-center , dose-finding phase I / II efficacy trial that included pediatric patients (< 18 years ) with Ph− B-cell precursor ALL who were refractory , had relapsed at least twice , or relapsed after an allogeneic hematopoietic cell transplantation ( alloHCT ).

In the phase I dose-finding portion , an independent Data Safety Monitoring Board recommended stepwise dosing of blinatumomab 5 / 15-μg / m ²/ day ). In the primary phase II portion evaluating safety and efficacy , patients are being monitored for a primary endpoint of complete remission within the first two cycles of blinatumomab treatment . Secondary endpoints include incidence of adverse events ( AEs ), the proportion of patients undergoing alloHCT after blinatumomab treatment , relapse-free survival , and overall survival . Minimal residual disease ( MRD ) response and complete MRD response were exploratory endpoints in both phases .

Among the 70 patients who received the recommended dose of blinatumomab

, the most common grade ≥3 AEs included anemia , thrombocytopenia , febrile neutropenia , hypokalemia , and neutropenia . All patients in the study have completed therapy and are being followed for long-term data .

Source : Amgen press release , May 4 , 2016 .

The FDA approved nivolumab for the treatment of classic Hodgkin lymphoma ( cHL ) for patients who have relapsed or progressed after autologous hematopoietic cell transplantation ( AHCT ) and post-transplantation brentuximab vedotin . The recommended dose of nivolumab is 3 mg / kg administered intravenously every two weeks until disease progression or unacceptable toxicity .

The approval was based on results from two single-arm , multi-center studies evaluating safety ( n = 263 ) and efficacy ( n = 95 ) in relapsed / refractory cHL patients treated with single-agent nivolumab . Patients had received a median five prior systematic regimens ( range = 3-15 regimens ) and received a median 17 doses of nivolumab ( range = 3-48 doses ).

The median time-to-response was 2.1 months ( range = 0.7-5.7 months ), and the objective response rate ( primary endpoint ) was 65 percent ( 95 % CI 55- 75 ), with 58 percent achieving partial remission and 7 percent achieving complete remission . The estimated duration of response ( secondary endpoint ) was 8.7 months .

Most of the patients received auto- HCT ( 98 %).

The most common any-grade treatment-related AEs ( reported in ≥20 % of patients ) included fatigue , upper respiratory tract infection , cough , pyrexia , and diarrhea . Other common AEs ( reported in ≥10 % of patients ) included rash , pruritus , musculoskeletal pain , nausea , vomiting , abdominal pain , headache , peripheral neuropathy , arthralgia , dyspnea , infusion-related reactions ( IRRs ), and hypothyroidism or thyroiditis . Serious AEs were reported in 21 percent of patients and included pneumonia , pleural effusion , pneumonitis , pyrexia , IRRs , and rash .

Nivolumab carries a warning for complications with alloHCT after nivolumab use . Transplant-related deaths have occurred and complications ( including hyper-acute and severe acute graft-versus-host disease , steroid-requiring febrile syndrome , hepatic venoocclusive disease , and other immunemediated AEs ) should be monitored .

Source : U . S . FDA press release , May 17 , 2016 .

The FDA granted breakthrough therapy designation for CPX-351 for the treatment of adult patients with therapyrelated acute myeloid leukemia ( AML ) or AML with myelodysplasia-related changes .

The designation was based on the results from a phase III study of older patients with previously untreated highrisk AML or AML with myelodysplasiarelated changes . The median overall survival ( primary endpoint ) was 9.6 months for those treated with CPX- 351 , compared with 6 months for those treated with the “ 7 + 3 ” regimen , representing a 31 percent reduction in the risk of death with CPX-351 ( hazard ratio = 0.69 ; p = 0.005 ).

At 12 and 24 months , 41.5 percent and 31.1 percent , respectively , of patients treated with CPX-351 were alive , compared with 27.6 percent and 12.3 percent , respectively , of those treated with 7 + 3 . Sixty-day all-cause mortality was 13.7 percent with CPX-351 and 21.2 percent with 7 + 3 .

AEs were similar among both treatment groups ; grade 3-5 hematologic AEs included infections , febrile neutropenia , and bleeding events .

Source : Celator Pharmaceuticals press release , May 19 , 2016 .