Acalabrutinib-Venetoclax Prolongs Survival in Previously Untreated Leukemia
For patients with previously untreated chronic lymphocytic leukemia (CLL), fixed-duration acalabrutinib-venetoclax with or without obinutuzumab significantly prolongs progression-free survival compared with chemoimmunotherapy, according to a study published online Feb. 5 in the New England Journal of Medicine.
Jennifer R. Brown, M.D., from Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3, open-label trial involving patients with CLL aged 18 years or older with an Eastern Cooperative Oncology Group performance-status score of 0 to 2, who did not have a 17p deletion or TP53 mutation. Patients were randomly assigned to receive acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, or chemoimmunotherapy with the investigator's choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (291, 286, and 290 [143 and 147], respectively).
The researchers found that at a median follow-up of 40.8 months, the estimated 36-month progression-free survival was 76.5, 83.1, and 66.5 percent with acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, and chemoimmunotherapy, respectively (hazard ratio for disease progression or death, 0.65 [P = 0.004], for acalabrutinib-venetoclax versus chemoimmunotherapy; P < 0.001 for acalabrutinib-venetoclax-obinutuzumab versus chemoimmunotherapy). The estimated 36-month overall survival was 94.1, 87.7, and 85.9 percent with acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, and chemoimmunotherapy, respectively. The most common adverse event of clinical interest of grade 3 or higher was neutropenia, which was reported in 32.3, 46.1, and 43.2 percent in the three groups, respectively. Ten, 25, and 21 patients died from COVID-19 in the three groups, respectively.
"Continued follow-up will be essential to clarify which patients would be most suitable for acalabrutinib-venetoclax and which for acalabrutinib-venetoclax-obinutuzumab," the authors write.
Several authors disclosed ties to the biopharmaceutical industry, including AstraZeneca, which funded the study.
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ASH: Auto-HCT Not Beneficial for Mantle Cell Lymphoma With Undetectable Residual Disease
Autologous hematopoietic cell transplant (auto-HCT) is not beneficial for patients with mantle cell lymphoma (MCL) in first complete remission (CR) with undetectable minimal residual disease (uMRD), according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego.
Timothy S. Fenske, M.D., from the Medical College of Wisconsin in Milwaukee, and colleagues conducted a four-arm trial involving patients with MCL between 18 and 70 years of age and in first remission. Patients in CR with uMRD at 1 in 10-6 sensitivity (uMRD6) were randomly assigned to arm A (auto-HCT + three years of maintenance rituximab [MR]) or arm B (three years of MR alone). Patients with MRD-positive CR or MRD-indeterminate CR both received auto-HCT + three years of MR (arms C and D, respectively). The primary end point was to compare survival in arms A and B.
From August 2017 to July 2024, 257, 259, 49, and 85 patients were enrolled in arms A, B, C, and D, respectively. The researchers found that the estimated overall survival hazard ratios for arms A and B in all randomized and treated-as-assigned patients (516 and 375, respectively) were 1.11 (95 percent confidence interval, 0.71 to 1.74; P = 0.66) and 1.00 (95 percent confidence interval, 0.58 to 1.74; P = 0.99), and crossed the boundary for futility. Three-year overall survival was 82.1 and 82.7 percent, respectively, for arms A and B in all randomly assigned patients, and 86.2 and 84.8 percent, respectively, in those treated as assigned.
"In this interim analysis, in the era of highly effective induction and maintenance regimens, MCL patients in first CR with uMRD6 did not benefit from consolidative auto-HCT," the authors write.
Several authors disclosed ties to the pharmaceutical and biotechnology industries.
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Anti-CD20 Therapy Shows No Effect on Disability Progression in MS
For patients with primary progressive multiple sclerosis (PPMS), the time to confirmed disability progression (CDP) does not differ for those who are anti-CD20-treated and untreated, according to a study published online Sept. 25 in Neurology.
Marion Hay, M.D., from Rennes University Hospital in France, and colleagues analyzed CDP in a cohort of patients with PPMS treated with anti-CD20 therapies versus a weighted untreated control cohort in a retrospective study using data from the French MS registry. A total of 1,184 patients met the inclusion criteria: 426 treated and 758 untreated (median age, 56 years; 52.7 percent female).
Among treated patients, 295 and 131 received rituximab and ocrelizumab, respectively. The researchers found that anti-CD20-treated patients were younger and had more active disease at baseline. There was no statistical difference observed in time to first CDP. A nonsignificant trend toward fewer patients relapsing in the treated group was observed in time to first relapse analysis. No significant difference was seen between the two groups for magnetic resonance imaging activity. Male sex and MS duration were risk factors associated with CDP in the treated group. Serious infection incidence ratios were 6.67 and 2.67 per 100 person-years in the treated and untreated groups, respectively.
"Our results indicate that there should be a constant evaluation of all available data to ascertain the best risk/benefit ratio for patients with PPMS, especially for newly diagnosed patients for whom inflammatory activity is very often not well defined," the authors write.
Several authors disclosed ties to the pharmaceutical industry.
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Glofitamab + GemOx Superior to Rituximab + GemOx for Lymphoma
Glofitamab (Glofit) plus gemcitabine and oxaliplatin (GemOx) is superior to rituximab (R)-GemOx for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), according to a study presented at the annual hybrid congress of the European Hematology Association, held from June 13 to 16 in Madrid.
Jeremy Abramson, M.D., from the Massachusetts General Hospital Cancer Center in Boston, and colleagues examined the efficacy and safety of Glofit-GemOx versus R-GemOx in patients with R/R DLBCL after one or more prior lines of therapy. A total of 274 patients were randomly assigned in a 2:1 ratio to receive Glofit-GemOx or R-GemOx (183 and 91 individuals, respectively).
The researchers observed a significant overall survival benefit with Glofit-GemOx versus R-GemOx at primary analysis (cutoff date, March 29, 2023). Median overall survival was not reached for Glofit-GemOx versus nine months for R-GemOx at a median follow-up of 11.3 months. Independent review committee-assessed progression-free survival and complete remission rate demonstrated a significant benefit for Glofit-GemOx. Glofit-GemOx continued to demonstrate superior median overall survival, median progression-free survival, and complete remission rates at follow-up analysis conducted once all patients had completed therapy (cutoff date, Feb. 16, 2024; median follow-up, 20.7 months) versus R-GemOx. Adverse event rates were higher with Glofit-Gemox than R-GemOx, including grade 3 to 4 and grade 5 adverse events and serious adverse events; however, the rates were similar after adjustment for exposure differences.
"Glofitamab in combination with GemOx showed clinically significant improvement in overall survival, as well as key secondary end points, and the benefits were reinforced with an additional 11 months of follow-up," Abramson said in a statement.
The study was funded by Genentech, the manufacturer of glofitamab.
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Biosimilar Biologics Do Not Always Reduce Out-of-Pocket Costs
TUESDAY, April 2, 2024 (HealthDay News) -- Biosimilar competition is not consistently associated with lower out-of-pocket (OOP) costs for commercially insured outpatients, according to a study published online March 29 in JAMA Health Forum.
Kimberly Feng, M.D., from Brigham and Women’s Hospital in Boston, and colleagues investigated whether biosimilar competition is associated with lower OOP spending for patients using biologics. The analysis included national claims data (Optum Clinformatics Data Mart) for 190,364 individuals (younger than 65 years of age) with outpatient claims for one of seven clinician-administered biologics (filgrastim, infliximab, pegfilgrastim, epoetin alfa, bevacizumab, rituximab, and trastuzumab) from January 2009 through March 2022.
The researchers found that annual OOP costs increased before and after biosimilar availability. Compared with the year before biosimilar competition, two years after the start of biosimilar competition, the adjusted odds ratio of nonzero annual OOP spending was 1.08 and average nonzero annual spending was 12 percent higher. Claims for biosimilars were more likely than reference biologics to have nonzero OOP costs (adjusted odds ratio, 1.13) but had lower mean nonzero OOP costs (adjusted mean ratio, 0.92). There was variance by drug.
"Findings of this study suggest that the introduction of biosimilar competition did not systematically lower patient OOP spending on biologics, highlighting the need for targeted policy interventions to ensure that savings from biosimilar competition improves affordability for patients," the authors write.
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