Today, I'll be sharing a brief update on key developments in hematology, highlights, insights from the general live session, New Drug Updates: Hematologic Malignancies, and what these updates really mean for advanced practitioners. This session highlighted five new drug approvals, six new indications, formulation updates, and emerging further directions.
So, let's begin. One notable drug is linvoseltamab, a bispecific for heavily pre-treated relapsed or refractory multiple myeloma. In the phase I LINKER-MM1 trial, linvoseltamab demonstrated a 71% objective response rate and a manageable side safety profile, with cytokine release syndrome as the most common adverse event. Patients achieving a very good partial response by week 24 transitioned to this once-every-four-week dosing. Some practices might be already doing this, so this was a really great trial to show proof of concept. Of note, it is unique from the other bispecifics in this arena, as it's administered IV and has a shorter step-up dosing.
Moving on to some updated indications. So, asciminib, a STAMP inhibitor in CML, targets both wild-type and BCR::ABL, including T315I. The phase III ASC4FIRST trial showed a 68% major molecular response at 48 weeks, vs 49% for standard TKIs. It showed fewer cardiovascular and hematologic adverse effects. Clinically, for asciminib, patients should be fasting two hours before and one hour after taking asciminib. Monitoring for pancreatic, cardiovascular, and hypertension toxicities is important. It is a substrate inhibitor for several CYP3A4 enzymes. So, for example, it interacts with atorvastatin and rosuvastatin, so alternatives like pravastatin or simvastatin are recommended. Something I would like to learn more about is how will we incorporate asciminib to first-line therapy for CML compared to the other TKIs? Specifically, I'm curious about which patient populations might be the right fit for asciminib up front, and how will this data influence our treatment sequencing and decision-making every day in clinical practice?
Continuing on with updates and indications, we have acalabrutinib. In the ECHO trial, which evaluated whether adding acalabrutinib, a second-generation BTK inhibitor to bendamustine plus rituximab, improves outcomes in previously untreated mantle cell lymphoma patients aged 65 and older who are ineligible for stem cell transplant. This study demonstrated improved progression-free survival 66.4 months vs 49.6 months with a BR alone. Of note, the new tablet formulation avoids proton pump inhibitor interactions, and perioperative management is required for holding the drug 3 to 7 days, depending on the procedure, before surgery.
Next up, we have tafasitamab, which is combined with R-squared, or rituximab and lenalidomide, for relapsed/refractory follicular lymphoma in the InMIND study vs R-squared. Results showed improved median PFS to 22.4 months vs 13.9 months, with expected toxicities. Considering infection prophylaxis and immunoglobulin therapy remain very important for this agent.
And finally, zanubrutinib. Talking about a new formulation, it's now available in a 160 mg tablet with functional scoring, so this helps reduce pill burden while maintaining the 320 mg daily dose. This updated formulation would hope to improve patient adherence, supporting our goal of patient-centered care.
