Caroline Seymour

The FDA has granted an orphan drug designation to paxalisib for use as a potential therapeutic option for patients with atypical rhabdoid and teratoid tumors, a rare and highly aggressive pediatric brain cancer.

The European Medicines Agency has verified its type II variation application to extend the indication for lisocabtagene maraleucel to include the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma, who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant.

Adding talimogene laherparepvec to pembrolizumab led to encouraging responses with a manageable safety profile in patients with advanced melanoma who progressed on prior anti–PD-1 therapy, most notably in the adjuvant setting, according to findings from the phase 2 MASTERKEY-115 trial.

Duvelisib and oral azacitidine are each being studied in combination with CHOP/CHOEP chemotherapy in patients with previously untreated CD30-negative peripheral T-cell lymphoma in the randomized phase 2 Alliance A059102 trial.

The combination of abemaciclib and fulvestrant led to encouraging responses when used as neoadjuvant therapy which translated to high complete gross resection rates in patients with advanced, low-grade serous ovarian, fallopian tube, and peritoneal carcinoma.

The bispecific antibody REGN5458 elicited rapid responses that were further characterized by their depth, durability, and low incidence of cytokine release syndrome in patients with relapsed/refractory multiple myeloma.

The combination of talquetamab and daratumumab led to early onset and durable responses that deepened over time in patients with heavily pretreated multiple myeloma, most of whom were anti-CD38 refractory, according to findings from the phase 1b TRIMM-2 study.

Decitabine demonstrated a comparable overall survival and rate of hematopoietic stem cell transplant in addition to a lower incidence of adverse effects vs induction chemotherapy with daunorubicin and cytarabine in older patients at least 60 years of age with acute myeloid leukemia.

The combination of the PD-1 antibody sintilimab and decitabine elicited potent clinical activity and manageable safety with no grade 4 or 5 treatment-related adverse effects as frontline therapy in patients with higher-risk myelodysplastic syndrome, according to preliminary results from a phase 2 trial.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2022 ASCO Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

FOLFOXIRI plus bevacizumab led to a significant improvement in progression-free survival, objective response rate, and R0/1 resections vs FOLFOX/FOLFIRI plus bevacizumab but resulted in increased toxicity in patients with initially unresectable colorectal cancer liver metastases and right-sided and/or RAS- or BRAF V600E–mutated primary tumors.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2022 ASCO Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

The combination of lenalidomide (Revlimid), bortezomib, and dexamethasone (RVd) plus autologous stem cell transplant as initial therapy followed by lenalidomide maintenance demonstrated a significant improvement in progression-free survival vs RVd alone followed by lenalidomide maintenance in patients with newly diagnosed multiple myeloma.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2022 ASCO Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

SOT101 alone and in combination with pembrolizumab demonstrated a favorable safety profile with no additional toxicities reported and promising efficacy among patients with advanced solid tumors, according to findings from the phase 1 AURELIO-03 trial.

Brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine demonstrated a significant reduction in the risk of death vs doxorubicin, bleomycin, vinblastine, and dacarbazine, with a manageable safety profile consistent with prior findings in patients with previously untreated stage III/IV classical Hodgkin lymphoma.

Nurix Therapeutics has initiated an ongoing phase 1 trial to examine NX-2127, an immunomodulatory oral BTK inhibitor, in patients with chronic lymphocytic leukemia.

The FDA has approved the biologics license application for pegfilgrastim-pbbk, a biosimilar referencing Neulasta for the treatment of neutropenia.

The addition of sorafenib to conventional chemotherapy was safe and demonstrated evidence of improved outcomes in pediatric patients with FLT3-ITD–positive acute myeloid leukemia.

Although lower fatality rates were reported during the omicron wave of the COVID-19 pandemic in patients with chronic lymphocytic leukemia, close monitoring and preemptive antiviral therapy is still recommended following a positive SARS-CoV-2 test, particularly in patients with close hospital contacts and those older than 70 years of age with at least one comorbidity.

The FDA has lifted a partial clinical hold on the phase 1 NEON-2 trial investigating the use of davoceticept in combination with pembrolizumab in adult patients with advanced solid tumors or lymphoma.

The European Commission approved pembrolizumab for use in combination with chemotherapy as neoadjuvant therapy, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.

The FDA has accepted and filed a biologics license application for mirvetuximab soravtansine for the treatment of patients with folate receptor alpha–high, platinum-resistant ovarian cancer who have previously received between 1 and 3 systemic therapies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.

The addition of the IL15RaFc superagonist N-803 to Bacillus Calmette–Guérin led to prolonged complete responses and disease-free survival (DFS) in patients with BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ and papillary histology, respectively.

The FDA has granted a breakthrough therapy designation to repotrectinib for the treatment of patients with ROS1-positive metastatic non–small cell lung cancer who have been previously treated with one ROS1 TKI and have not received prior platinum-based chemotherapy.

Reshma Mahtani, DO, discusses the use of antibody-drug conjugates, tyrosine kinase inhibitors, CDK4/6 inhibitors, and PARP inhibitors across HER2-positive breast cancer, hormone receptor–positive, HER2-negative breast cancer, and triple-negative breast cancer.

The European Commission has granted an approval to pembrolizumab for the treatment of patients with select microsatellite instability–high or deficient mismatch repair solid tumors.

New data ranging from up-front approaches with targeted therapy to maintenance therapy, as well as emerging findings with novel agents continue to push the paradigm forward in acute myeloid leukemia and higher-risk myelodysplastic syndromes.

The FDA has granted a breakthrough therapy designation to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.