63rd ASH Annual Meeting and Exposition
December 11-14, 2021
  • Combination Small Molecules
  • Clinical and Epidemiological I
  • Clinical and Epidemiological II

642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Combination Small Molecules


Alessandra Tedeschi, Emmanuelle Ferrant, Ian W. Flinn, et al.

Zanubrutinib plus venetoclax is generally well-tolerated in this high-risk population. There were no new safety signals and no TLS was reported. Updated data on safety, efficacy, and biomarkers will be presented in the oral session.



Paolo Ghia, John N. Allan, Tanya Siddiqi, et al.

The results of first-line ibrutinib plus venetoclax in CLL patients with confirmed uMRD, according to the study authors, support the potential for treatment-free remission with fixed-duration treatment, even in patients with high-risk characteristics. High uMRD rates (2-year DFS rate 95% and 3-year PFS rate ≥95) were achieved. The safety profile of ibrutinib + venetoclax was congruent with the known safety profile for both active substances.



Carsten Utoft Niemann, Julie Dubois, Christian Brieghel, et al.

MRD-controlled time-limited treatment with ibrutinib and venetoclax for R/R-CLL could be carried out without progression after end-of-treatment. It results in a favorable risk-benefit profile without any new safety signals. In patients who were again MRD-positive the therapy could be successfully restarted. From this the study authors conclude that MRD-guided termination and resumption of targeted therapy in CLL is possible.



Tahla Munir, Carol Moreno, Carolyn Owen, et al.

Fixed-duration ibrutinib plus venetoclax orally demonstrated superior uMRD responses in elderly or unfit patients with previously untreated CLL. This was deeper and more sustainable than with chlorambucil plus obinutuzumab. See abstract for more info.



Barbara Eichhorst, Carsten Niemann, Arnon P. Kater, et al.

The time-limited therapies of GVe and GIVe showed superior uMRD rates in PB compared to CIT at 15 months. The uMRD rates in BM and CRR, especially for GVe and GIVe, were higher than in CIT. The safety profile was good in all arms.


642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I


Anthony R. Mato, John M. Pagel, Catherine C. Coombs, et al.

Pirtobrutinib showed promising efficacy in heavily pretreated CLL / SLL (including covalent BTKi, BCL2 inhibitors, BTK C481 mutations). The substance had a broad therapeutic spectrum and was well tolerated. Updated data will be presented in the oral session.



Jennifer A. Woyach, Ian W. Flinn, Farrukh T. Awan, et al.

MK-1026 demonstrated promising antitumor activity in a CLL / SLL that had been pretreated many times, including disease progression with previous covalent BTKi treatment. The safety profile turned out to be manageable.



Wojciech Jurczak, Andrzej Pluta, Malgorzata Wach, et al.

Even after 3 years, the effectiveness of Acala monotherapy was sustained while maintaining an acceptable tolerability profile. In patients with R / R-CLL, this follow-up means a significant PFS advantage over standard treatments. No new safety findings were found.


Hua-Jay J. Cherng, Raamis Khwaja, Rashmi Kanagal-Shamanna, et al.

The study authors report favorable 4-year PFS and OS rates of 72.7% and 87.2% in patients with TP53-altered CLL with BTKi-based first-line therapy. See abstract for more info.



Lindsey E. Roeker, Lori A. Leslie, Jake D. Soumerai, et al.The combination of BTKi, PI3Ki and anti-CD20 monoclonal antibody was well tolerated and effective. A uMRD was achieved in 71 percent of the evaluable patients. This “add-on” approach to continuous ibrutinib treatment induced deep remissions and thus allowed tailor-made, time-limited therapy and sustained treatment-free observation.


Constantine S. Tam, Krzysztof Giannopoulos, Wojciech Jurczak, et al.

Zanubrutinib, which was generally well tolerated (with low rates of atrial fibrillation), demonstrated a statistically significant improvement in PFS compared to BR as assessed by the independent review committee (IRC). Superiority was also observed in this registration study with PFS by investigator assessment (INV) and ORR from both IRC and INV. The study authors conclude that their data support the potential utility of zanubrutinib in the frontline management of patients with TN CLL / SLL.

642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological II


Cristina Bagacean, Rémi Letestu, Chadi Al Nawakil, et al.

See abstract for more info.



Gilad Itchaki, Lior Rokach, Ohad Benjamini, et al.

See abstract for more info.



Jennifer A. Woyach, Amy S. Ruppert, Nyla A. Heerema, et al.

The ibrutinib regimen is able to extend the PFS compared to the BR in older patients with treatment-naive CLL. The authors of the study support ibrutinib initial therapy for CLL with their data and support the justification for ibrutinib in high-risk diseases. See abstract for more info.



Matthew S. Davids, Danielle M. Brander, Svitlana Tyekucheva, et al.

During a median follow-up of 40.3 months, most patients treated with iFCR continued to have a deep response. This also affected patients with non-mutated IGHV. The safety profile is consistent with the individual toxicities of ibrutinib and FCR. The few relapses have all responded to re-treatment with ibrutinib.


Anne-Sophie Michallet, Anne Quinquenel, Remi Letestu, et al.

The preliminary results show a lower BM-MRD rate in the IV arm after nine months compared to the FCR arm. There is still significant and relatively similar toxicity between the two arms. According to the study authors, the BM-MRD rate should improve after prolonged exposure to the IV combination. The decision to determine the best therapeutic strategy will only be possible after analyzing the primary endpoint after 27 months.




Peter Hillmen, Alexandra Pitchford, Adrian Bloor, et al.

Ibrutinib plus rituximab resulted in a superior PFS compared to FCR with no difference in OS.


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