All Oncology News

The FDA has granted priority and standard review designations to the biologics license applications for exagamglogene autotemcel for the treatment of patients with sickle cell disease and transfusion-dependent beta thalassemia, respectively, marking the first CRISPR gene editing filings to be accepted for review by the FDA.

Administration of the selective ALK-2 inhibitor zilurgisertib alone or in combination with ruxolitinib was safe, well tolerated, and showed preliminary signals of clinical activity in patients with primary or secondary myelofibrosis and disease-related anemia.

The FGFR2 inhibitor RLY-4008 generated early evidence of efficacy in patients with cholangiocarcinoma harboring FGFR2 fusions, according to findings from the phase 1/2 ReFocus trial, which were presented at the 2023 ASCO Annual Meeting.

A full dose of lurbinectedin plus a low dose of doxorubicin was clinically active and tolerable in patients with advanced or metastatic soft tissue sarcomas, supporting its continued investigation in those with leiomyosarcoma.

The FDA has accepted and granted priority review designation to the new drug application for the combination of capivasertib and fulvestrant for the treatment of patients with hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after endocrine-based therapy.

Elizabeth Plimack, MD, MS, Deputy Director and professor in the Department of Hematology/Oncology at Fox Chase Cancer Center, has been appointed Treasurer of the American Society of Clinical Oncology.

Wonder can be used as a mechanism to humbly, and with some excitement, attain the competency that is required to gain mastery of your new environment.

Luke J. Mountjoy, DO, discusses the implications of the SEQUOIA and the ALPINE trial, the importance of coming up with feasible and effective treatment options for patients with 17p deletions and TP53 mutations, and the investigation of liso-cel in patients with relapsed/refractory CLL.

OMS906, a MASP-3 inhibitor, normalized hemoglobin, lactate dehydrogenase, and reticulocytes levels in patients with paroxysmal nocturnal hemoglobinuria.

Ibrutinib did not prolong survival vs placebo and is linked with increased susceptibility to bleeding in patients with asymptomatic early-stage chronic lymphocytic leukemia, suggesting that a watch-and-wait approach should continue as the standard for this population.

Gilteritinib led to a 48% reduction in disease recurrence for patients with FLT3-ITD–mutant acute myeloid leukemia and detectable minimal residual disease pre and post hematopoietic stem cell transplant compared with placebo, highlighting a role for treatment in this subgroup of patients.

Treatment with fixed-duration venetoclax plus rituximab continued to show superior survival benefit vs bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia, according to 7-year follow up data from the phase 3 MURANO trial.

Ziftomenib demonstrated clinical activity and a tolerable safety profile in heavily pretreated patients with relapsed/refractory NPM1-mutant acute myeloid leukemia.

The BET inhibitor BMS-986158 combined with ruxolitinib led to robust spleen volume reduction with acceptable tolerability in patients with myelofibrosis. When the BET inhibitor was combined with fedratinib, the safety profile was also determined to be manageable.

Administration of a single infusion of ciltacabtagene autoleucel prolonged progression-free survival, generated sustained responses, and continued to demonstrate a manageable safety profile in patients with relapsed/refractory multiple myeloma who were heavily pretreated, according to final results from the phase 1b/2 CARTITUDE-1 study.

Rusfertide demonstrated freedom from phlebotomy, sustained hematocrit control, and 12-week treatment completion in 69.2% vs 18.5% of patients with phlebotomy-dependent polycythemia vera who received placebo, meeting the primary end point of the phase 2 REVIVE trial.

The novel SYK inhibitor cevidoplenib dosed at 400 mg twice per day led to robust platelet responses in patients with persistent or chronic primary immune thrombocytopenia who did not respond or relapsed after at least 1 prior therapy.

Ruxolitinib was found to improve spleen volume and tumor symptom score in patients with myelofibrosis, irrespective of their anemia and transfusion status, according to data from a post-hoc analysis of the phase 3 COMFORT-I and -II trials.

Although the event rate did reach the expected level and longer follow-up is needed to adequately assess long-term toxicities, data from the phase 3 IELSG37 trial support the omission of radiotherapy in patients with primary mediastinal large B-cell lymphoma who achieve a complete metabolic response following chemoimmunotherapy.

Patients with intermediate-2 or high-risk myelofibrosis who received the novel JAK/ACVR1 inhibitor jaktinib experienced a statistically significant improvement in the proportion of patients with a spleen-volume reduction of at least 35% from baseline at week 24 vs those who were treated with hydroxyurea.

Patients with primary or secondary TP53 wild-type myelofibrosis who experienced suboptimal response to ruxolitinib had clinically meaningful improvements in spleen volume reduction with the addition of navtemadlin to ruxolitinib,

The combination of the BCMA- and GPRC5D-targeted bispecific antibodies, teclistamab and talquetamab, respectively, demonstrated encouraging overall response rates and was well tolerated in patients with relapsed or refractory multiple myeloma.

The combination of daratumumab plus bortezomib, cyclophosphamide, and dexamethasone, elicited a complete response (CR) rate of 40% and a CR or better rate of 43% in patients with multiple myeloma presenting with extramedullary disease.

Daratumumab maintenance therapy with or without pomalidomide provided a tolerable and feasible treatment option after salvage hematopoietic stem cell transplantation in patients with relapsed multiple myeloma.

Teclistamab continued to elicit deep and durable responses in patients with relapsed/refractory multiple myeloma, irrespective of being triple-class refractory, daratumumab-refractory, or refractory to last line of therapy.

The addition of daratumumab to frontline induction therapy prior to peripheral blood stem cell collection reduced the number of patients with newly diagnosed multiple myeloma who were able to meet their stem cell collection goals on first attempt.

Treatment with ponatinib plus reduced-intensity chemotherapy led to an improvement in minimal residual disease-negative complete remission rate compared with imatinib plus reduced-intensity chemotherapy in newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.

Treatment with pelabresib monotherapy led to a 60% confirmed complete or partial hematologic response at any time without incurring grade 4 or 5 treatment-related adverse effects in patients with high-risk essential thrombocythemia refractory or intolerant to hydroxyurea.

The addition of acalabrutinib to bendamustine and rituximab demonstrated potent and durable responses despite a high incidence of grade 3/4 adverse effects in patients with previously untreated and relapsed/refractory mantle cell lymphoma.

The combination of daratumumab, ixazomib, and dexamethasone produced rapid and encouraging responses rates following lenalidomide–based therapy in patients with relapsed/refractory multiple myeloma, according to findings from the final analysis of the phase 2 DARIA trial.