The Targeted Pulse: Orca-T Triumphs in GVHD Prevention, Ide-Cel Elicits Durable Responses in MM, and More

Ide-Cel Elicits Durable Responses for High-Risk Multiple Myeloma Relapse

Data from the phase 2 KarMMa-2 trial (NCT03601078) showed that the chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel (ide-cel; Abecma) elicited durable responses in cohort 2B. Patients included in the cohort (n=35) had high-risk multiple myeloma and had experienced an early relapse within 18 months of frontline therapy. To be eligible, patients needed to have received the frontline therapy with a proteasome inhibitor, immunomodulatory drug, and dexamethasone. They also needed to have measurable disease and an ECOG performance status of 0 or 1.

“Although a high proportion of patients had high tumor burden and high-risk cytogenetics, response rates were high,” Xavier Leleu, MD, MSc, PhD, head of the Myeloma Clinic at Poitiers University Hospital in Lille France, said during a presentation of the data at the 2024 European Hematology Association Congress.

Orca-T Triumphs in GVHD Prevention for Acute Leukemia and MDS

A retrospective study involving data from patients with hematologic malignancies evaluated the relative efficacy in preventing graft-vs-host disease (GVHD) using Orca-T compared with posttransplant cyclophosphamide (PTCy)-based hematopoietic cell transplantation (HCT). Investigators concluded that Orca-T has the potential to improve post-HCT outcomes compared with PTCy-based HCT for patients with acute leukemia and myelodysplastic syndrome.

“The posttransplant cyclophosphamide studies and the platform have shown significant reduction in chronic GVHD. There might be other ways that we can improve outcomes by reducing …toxicities and relapse,” Alexandra Gomez Arteaga, MD, said in an interview with Targeted OncologyTM. “Orca-T is a high precision immunotherapy that is a more organized approach to creating immune reconstitution.” Gomez Arteaga is a hematologist/oncologist in the bone marrow transplant and cellular therapy program at Weill Cornell Medicine in New York, New York.

225Ac-FL-020 Has Been Granted Fast Track Status By The FDA for mCRPC

225Ac-FL-020, which works to target prostate-specific membrane antigen, has been given fast track designation from the FDA for the management of metastatic castration-resistant prostate cancer. 225Ac-FL-020 is a potential best-in-class, next-generation actinium-225 (225Ac)-based PSMA-targeting radionuclide drug conjugate that utilizes targeted alpha-radiotherapy to selectively attack cancer cells and minimize harm to healthy tissues.

“The FDA fast track designation for 225Ac-FL-020 underscores the critical need for innovative and effective treatments for mCRPC,” Steffen Heeger, MD, MSc, chief medical officer of Full-Life, said in a press release. “This designation will enable us to collaborate more closely with the FDA throughout the development process, potentially accelerating the availability of 225Ac-FL-020 to patients.”

Adding Glofitamab to Chemotherapy Boosts Survival in R/R DLBCL

The addition of glofitamab-gxbm (Columvi) to gemcitabine and oxaliplatin led to clinically meaningful improvement in overall survival and progression-free survival in the phase 3 STARGLO study (NCT04408638). The treatment arm was compared with the control arm of rituximab (Rituxan) and gemcitabine/oxaliplatin in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who were not eligible for autologous stem cell transplant.

“Glofitamab is the first CD20 × CD3 bispecific antibody to demonstrate a survival benefit in DLBCL in a randomized phase 3 trial,” Jeremy S. Abramson, MD, director of the Jon and Jo Ann Hagler Center for Lymphoma at the Massachusetts General Hospital Cancer Center, and associate professor of medicine at Harvard Medical School, in Boston, Massachusetts, said in a presentation during the meeting. “These results support the use of glofitamab plus gemcitabine and oxaliplatin for the treatment of relapsed/refractory DLBCL.”

Lenvatinib’s Advantage Confirmed in RAI-Refractory DTC Through Real-World Data

A study using real-world US experiences confirmed that lenvatinib (Lenvima) was consistently effective across a diverse cohort of patients with radioiodine (RAI)-refractory differentiated thyroid cancer, including those with BRAF-mutated, wild-type and BRAF untested tumors. Francis P. Worden, MD, professor of medicine at the University of Michigan Rogel Cancer Center, Ann Arbor, discussed the implications of this research for patients with RAI-refractory DTC with Targeted Oncology^TM.

“Now is the time for us to start looking at lenvatinib in a real-world setting to see how the drug is being used… Interestingly enough, we noticed overwhelmingly that in our real-world experience that we published at the end of December last year, that the majority of the [patients], when we surveyed providers from all around the country who treat patients [with thyroid cancer] who were refractory to iodine, the starting dose for the vast majority of [patients] was 24 mg, and that response rates were somewhere around 72%, which was higher than in the SELECT trial [NCT01321554],” Worden said.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.

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