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Phase II Results Show Activity of Polatuzumab Vedotin Combination in DLBCL
The CD79b-targeting antibody drug conjugate polatuzumab vedotin , in combination with rituximab , cyclophosphamide , doxorubicin , and prednisone ( R-CHP ), was able to be administered safely in patients with newly diagnosed diffuse large B-cell lymphoma ( DLBCL ) in an initial , phase Ib / II dose-escalation study . Results from the phase II portion of the trial were presented at the 22nd Congress of the European Hematology Association , and investigators reported that the combination “ produced promising response rates ” in this patient population .
Hervé Tilly , MD , from Centre Henri Becquerel at the University of Rouen in France , and colleagues evaluated the combination treatment in 45 patients ( median age = 69 years ; range not provided ): five patients from the dose-escalation phase and 40 from the dose-expansion phase .
Most patients ( 93 %) were > 60 years old with stage III / IV disease ( 82 %) and an International Prognostic Index ( IPI ) score of three to five ( 78 %). “ The majority of the patients in this trial represented a poor prognosis group [ based on ] age and IPI [ score ],” the authors noted .
Per the phase Ib / II trial ’ s protocol , all patients had previously untreated , newly diagnosed DLBCL and received six or eight 21-day cycles of polatuzumab vedotin 1.8 mg / kg ( the recommended phase II dose ) plus R-CHP at standard doses :
• cyclophosphamide 750 mg / m 2 intravenously ( IV ) every 3 weeks
• doxorubicin 50 mg / m 2 IV every 3 weeks
• prednisone 100 mg orally oncedaily for 5 days every 3 weeks
cases of grade 2 / 3 peripheral neuropathy occurred during or after the fifth treatment cycle .
Six patients required dose reductions of polatuzumab vedotin and one patient required a dose reduction of cyclophosphamide and doxorubicin . Overall , four patients discontinued polatuzumab vedotin ( related to the grade 5
ADYNOVATE ® is FDA approved for patients of all ages with Hemophilia A
PROVEN PROPHYLAXIS + SIMPLE ,* TWICE-WEEKLY
DOSING SCHEDULE = moments atrial fibrillation , peripheral neuropathy , E . coli urinary tract infection , and worsening essential tremor ).
After patients completed six or eight treatment cycles , the overall response rate ( assessed by positron emission tomography ) for 44 evaluable patients was 91 percent , including a complete response ( CR ) rate of 78 percent and a partial response rate of 13 percent . Three patients ’ disease progressed .
Of the 29 patients with gene-expression data available , the cell of origin was germinal center B cell-like ( GCB ) in 48 percent of cases ( n = 14 ), activated B cell-like
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THEIR WAY
* ADYNOVATE allows patients to infuse on the same 2 days every week .
• rituximab 375 mg / m 2 IV every 3 weeks
All patients received at least one dose of the study drug , and most completed six ( n = 23 ) or eight ( n = 17 ) cycles .
All patients experienced at least one adverse event ( AE ), and grade 3 / 4 AEs occurred in 58 percent of patients . The most common grade 3 / 4 AEs included neutropenia ( 27 %) and febrile neutropenia ( 27 %). Serious AEs were reported in 17 patients ( 38 %), the most common being febrile neutropenia and neutropenia , while one patient experienced grade 5 atrial fibrillation .
Peripheral neuropathy occurred in 18 patients ( 40 %), mostly grade 1 ( n = 12 ). The authors noted that all
30 ASH Clinical News
ADYNOVATE [ Antihemophilic Factor ( Recombinant ), PEGylated ] Important Information
Indications
ADYNOVATE , Antihemophilic Factor ( Recombinant ), PEGylated , is a human antihemophilic factor indicated in children and adults with hemophilia A ( congenital factor VIII deficiency ) for :
• On-demand treatment and control of bleeding episodes
• Perioperative management
• Routine prophylaxis to reduce the frequency of bleeding episodes
Limitation of Use ADYNOVATE is not indicated for the treatment of von Willebrand disease .
DETAILED IMPORTANT RISK INFORMATION
CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE , to the parent molecule ( ADVATE [ Antihemophilic Factor ( Recombinant )]), mouse or hamster protein , or excipients of ADYNOVATE ( e . g . Tris , mannitol , trehalose , glutathione , and / or polysorbate 80 ).
WARNINGS & PRECAUTIONS Hypersensitivity Reactions
Hypersensitivity reactions are possible with ADYNOVATE . Allergic-type hypersensitivity reactions , including anaphylaxis , have been reported with other recombinant antihemophilic factor VIII products , including the parent molecule , ADVATE . Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema , chest tightness , dyspnea , wheezing , urticaria , and pruritus . Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur .