Advertisement


Catherine C. Coombs, MD, on B-Cell Malignancies and Long-Term Safety of Pirtobrutinib

2023 ASCO Annual Meeting

Advertisement

Catherine C. Coombs, MD, of the University of California, Irvine, discusses prolonged pirtobrutinib therapy, which continues to demonstrate a safety profile amenable to long-term administration at the recommended dose without evidence of new or worsening toxicity signals. The safety and tolerability observed in patients on therapy for 12 months or more were similar to previously published safety analyses of all patients enrolled, regardless of follow-up (Abstract 7513).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
Catherine C. Coombs: BTK has proven to be an invaluable target of inhibition for the treatment of a number of B-cell malignancies. However, the use of BTK inhibitors is dependent upon their continuous administration. Therefore, safety and tolerability are paramount importance to maintain maximal efficacy. In this abstract, we reviewed the long-term safety data of Pirtobrutinib from the Phase 1/2 BRUIN trial. The trial design enrolled patients with a number of B-cell malignancies. The entire safety population was over 700 patients. However, in this post-hoc analysis, we reviewed the patients on treatment for over a year, which amounted to 326 patients. As one would expect, this population was enriched for patients with the more chronic B-cell malignancies, and so the largest population was CLL and SLL though there were about 40 patients with mantle cell lymphoma and Waldenström's macroglobulinemia. The safety aspects that were reviewed included all of the common side effects from this drug, which fortunately were very uncommon, especially grade three or higher AEs. In reviewing treatment exposure adjusted AE rates, what we determined was that in comparing patients on the drug for over a year compared to the entire safety population, there does not appear to be an increased risk in toxicity for patients that are on the drug for longer periods of time. This is further supported by the low incidences of discontinuation for the drug, especially in those patients who were on the drug for over a year where only 1.2% of patients discontinued due to side effects. In addition, regarding the class effects of BTK inhibitors that we worry about, the incidences of atrial fibrillation, bleeding, and hypertension were all extremely low and did not suggest a temporal relationship to Pirtobrutinib. In conclusion, we can see that now with long-term administration of Pirtobrutinib, this drug is exquisitely safe and can inhibit its target, BTK, for maximal benefit to our patients with these malignancies.

Related Videos

Myelodysplastic Syndromes
Supportive Care

Aaron T. Gerds, MD, on Anemia in Myelofibrosis: New Data on Treatment With Luspatercept

Aaron T. Gerds, MD, of Cleveland Clinic Taussig Cancer Institute, talks about treating the anemia many patients with myelofibrosis experience because of JAK inhibitor therapy. The ACE-536-MF-001 study showed that luspatercept improved anemia and transfusion burden in this population, with a safety profile consistent with that in previous studies (Abstract 7016).

Skin Cancer
Immunotherapy

Jason J. Luke, MD, on Melanoma Adjuvant Therapy: Final Analysis of KEYNOTE-716

Jason J. Luke, MD, of the University of Pittsburgh Medical Center Hillman Cancer Center, discusses adjuvant pembrolizumab, which, in previous results, improved distant metastasis– and recurrence-free survival in patients with resected stage IIB or IIC melanoma vs placebo. After a median follow-up of 39.4 months, adjuvant pembrolizumab continued to show a benefit over placebo, with no new safety signals (Abstract LBA9505).

Bladder Cancer

Arlene O. Siefker-Radtke, MD, on Metastatic Urothelial Carcinoma: New Data on Erdafitinib and Cetrelimab From the NORSE Study

Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses the combination of erdafitinib and cetrelimab, which demonstrated clinically meaningful activity and was well tolerated in cisplatin-ineligible patients with metastatic urothelial carcinoma and fibroblast growth factor receptor alterations (Abstract 4504).

Lung Cancer
Immunotherapy

Narjust Florez, MD, and Heather A. Wakelee, MD, on Early-Stage NSCLC: Phase III Findings From KEYNOTE-671 on Pembrolizumab and Platinum-Based Chemotherapy

Narjust Florez, MD, of Dana-Farber Cancer Institute, and Heather A. Wakelee, MD, of Stanford University, Stanford Cancer Institute, discuss new data supporting neoadjuvant pembrolizumab plus chemotherapy followed by surgery and adjuvant pembrolizumab as a promising new treatment option for patients with resectable stage II, IIIA, or IIIB (N2) non–small cell lung cancer (NSCLC) (Abstract LBA100).

Solid Tumors

Funda Meric-Bernstam, MD, on HER2-Expressing Solid Tumors: Efficacy and Safety of Trastuzumab Deruxtecan

Funda Meric-Bernstam, MD, of The University of Texas MD Anderson Cancer Center, discusses interim results from the DESTINY-PanTumor02 trial, the first tumor-agnostic global study of fam-trastuzumab deruxtecan-nxki (T-DXd) in a broad range of HER2-expressing solid tumors. This agent showed an encouraging overall response rate, particularly in patients with IHC 3+ expression; durable clinical benefit; and a manageable safety profile in these heavily pretreated patients. T-DXd may be a potential new treatment option for this population (Abstract LBA3000).

Advertisement

Advertisement




Advertisement