{"id":10217,"date":"2020-06-19T14:54:10","date_gmt":"2020-06-19T18:54:10","guid":{"rendered":"https:\/\/themedicalxchange.com\/?p=10217"},"modified":"2021-09-01T15:38:01","modified_gmt":"2021-09-01T19:38:01","slug":"2423-next-generation-btk-inhibitors-fulfilling-promise-for-cll-in-long-term-follow-up","status":"publish","type":"post","link":"https:\/\/themedicalxchange.com\/en\/2020\/06\/19\/2423-next-generation-btk-inhibitors-fulfilling-promise-for-cll-in-long-term-follow-up\/","title":{"rendered":"Next-Generation BTK Inhibitors Fulfilling Promise for CLL in Long-Term Follow-Up"},"content":{"rendered":"

The new data support the premise that the greater BTK selectivity of the next-generation therapies provides efficacy and safety advantages relative to ibrutinib, the first BTK inhibitor. This included follow-up data out to a median of 55 months with acalabrutinib, which was recently approved in Canada for first-line and relapsed\/refractory (R\/R) CLL. Other next-generation BTK inhibitors in development, such as zanubrutinib, are also showing high rates of activity and low relative levels of toxicity in B-cell diseases.<\/p>\n

90% Improvement in Progression-Free Survival at 28 Months<\/h2>\n

The data from the ELEVATE-TN and ASCEND trials, which were conducted in treatment-na\u00efve and R\/R CLL, respectively, provided the basis for the recent acalabrutinib approval in Canada. Both studies associated this next-generation BTK inhibitor with a favourable safety and efficacy profile. Now, new follow-up data show the effect is sustained.<\/p>\n

\u201cEven as a monotherapy in the long-term follow-up, acalabrutinib achieved high and persistent responses regardless of genomic features,\u201d reported Dr. John C. Byrd, chairman of leukemia research, Ohio State University Comprehensive Cancer Center, Columbus.\u00a0
<\/p>\n

\n

\u201cEven as a monotherapy in the long-term follow-up, acalabrutinib achieved high and persistent responses.\u201d<\/p>\n<\/blockquote>\n

The long-term follow-up data were derived from ACE-CL-001, the first phase 2 trial with acalabrutinib in treatment-na\u00efve patients. With a 97% overall response rate (ORR), the initial response rates were reported to be similar across groups defined as high-risk by RAI stage, presence of bulky disease, or adverse genomic features. Now, after a median of more than four years (53 months) of follow-up, disease control is being sustained in most of those initially enrolled. At the 48-month timepoint, the median duration of response (DOR), event-free survival (EFS), and progression-free survival (PFS) have not been reached, Dr. Byrd reported.\u00a0The proportion of patients in EFS at 48 months is 90% \u00a0(Figure 1<\/a>). The PFS at 48 months was 96%.<\/p>\n

Of the 99 patients who entered the trial, 85 (86%) are still receiving acalabrutinib. Only three patients have left the study due to progressive disease. Only six discontinued due to an adverse event.<\/p>\n

There have been no new adverse events observed over the long-term follow-up, but Dr. Byrd did report that all of the most common adverse events, including diarrhea, headache, nausea, and hypertension diminished over the period of extended treatment (Figure 2<\/a>).<\/p>\n

With these data, which represent \u201cthe longest safety and efficacy follow-up to date with acalabrutinib in treatment-na\u00efve CLL patients,\u201d Dr. Byrd said that evidence confirms that sustained benefit follows the high rates of response previously reported.<\/p>\n

ASCEND Final Results<\/h2>\n

Final results from the phase 3 ASCEND trial, which established the efficacy of acalabrutinib in R\/R CLL were also presented at EHA25 Virtual. In that trial, 310 patients were randomized to 100-mg twice-daily acalabrutinib or investigator\u2019s choice of rituximab plus idelalisib (IdR) or bendamustine.<\/p>\n

\u201cAt a median follow-up of 22 months, the median PFS was not reached in the acalabrutinib arm,\u201d reported Dr. Paolo Ghia, Director of the Strategic Research Program on CLL, University Vita-Salute San Raffaele, Milan, Italy. Relative to a median PFS of 16.8 months, the rates of PFS at 18 months were 82% and 48% for the acalabrutinib and comparator arms respectively, producing a 77% risk reduction (HR 0.23; P<\/em><0.0001).
<\/p>\n

\n

\u201cAt a median\u00a0follow-up of 22 months, the median PFS was not reached in the acalabrutinib arm.\u201d<\/p>\n<\/blockquote>\n

At 80% in both arms, there is no difference in overall survival (OS) rate in follow-up so far, but acalabrutinib was far better tolerated. The rates of study discontinuations due to an adverse effect were 16% versus 56% (Figure 3<\/a>).<\/p>\n

Data for Waldenstr\u00f6m\u2019s Macroglobulinemia<\/h2>\n

The promise of other next-generation BTK inhibitors, such as zanubrutinib, is also attributed to relative BTK selectivity. In Waldenstr\u00f6m\u2019s macroglobulinemia (WM), the next-generation zanubrutinib showed greater activity than ibrutinib in the head-to-head phase 3 ASPEN trial even though significance for superiority on the primary combined endpoint of complete (CR) and very good partial responses (VGPR) was missed (28.4% vs 19.2%; P<\/em>=0.092).<\/p>\n

“Other indicators, such as investigator-assessment of clinical response [30.4% vs. 18.2%; P<\/em>=0.03] did suggest an advantage for zanubrutinib,\u201d reported Dr. Meletios Dimopoulos, Chairman, Department of Clinical Therapeutics, University of Athens, Greece.<\/p>\n

Fewer treatment discontinuations for adverse events in the zanubrutinib arm (4.0% vs. 9.2%) support the premise that the greater selectivity of the newer BTK inhibitors will confer an advantage for safety and efficacy relative to first-generation ibrutinib.<\/p>\n

Conclusion<\/h2>\n

Long-term data support exceptional activity for the next-generation BTK inhibitors in CLL and potentially other B-cell malignancies. By demonstrating relatively low rates of serious toxicities and durable response, the trial data validate the importance of BTK specificity.<\/p>\n","protected":false},"excerpt":{"rendered":"

Virtual Meeting <\/b>\u2013 New follow-up data presented at EHA25 Virtual have greatly expanded the evidence that next-generation Bruton tyrosine kinase (BTK) inhibitors are providing far more durable control in the B-cell malignancies to which they have been compared than the first-generation agent. In chronic lymphocytic leukemia (CLL), follow-up data showing durable benefit with a next-generation BTK inhibitor is now out to four years, confirming sustained disease control with no unexpected toxicity.<\/p>\n","protected":false},"author":9,"featured_media":10240,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"tags":[542,565],"class_list":["post-10217","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","tag-542","tag-eha","area_tag-hematology","area_tag-oncology"],"acf":[],"yoast_head":"\nNext-Generation BTK Inhibitors Fulfilling Promise for CLL in Long-Term Follow-Up - The Medical Xchange<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/themedicalxchange.com\/en\/2020\/06\/19\/2423-next-generation-btk-inhibitors-fulfilling-promise-for-cll-in-long-term-follow-up\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Next-Generation BTK Inhibitors Fulfilling Promise for CLL in Long-Term Follow-Up - The Medical Xchange\" \/>\n<meta property=\"og:description\" content=\"Virtual Meeting \u2013 New follow-up data presented at EHA25 Virtual have greatly expanded the evidence that next-generation Bruton tyrosine kinase (BTK) inhibitors are providing far more durable control in the B-cell malignancies to which they have been compared than the first-generation agent. 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