From Axatilimab to Zanubrutinib: Treatment Updates Abound

Key trial results that may soon shape clinical practice in hematology and oncology were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, California, from December 9 to 12, 2023. Below are some highlights from the conference.

Image credit: Анна Ковальчук | stock.adobe.com

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Zanubrutinib Continues to Demonstrate Progression-Free Survival Advantage vs Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia

Zanubrutinib (Brukinsa; BeiGene) continues to show improved progressionfree survival (PFS) over ibrutinib (Imbruvica; Pharmacyclics LLC, Janssen Biotech Inc) among patients with relapsed/ refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). With a 39-month extended follow-up of the randomized and global phase 3 ALPINE study (NCT03734016), zanubrutinib sustained its PFS benefit with an HR of 0.68 and a 3-year landmark estimate of 64.9% PFS rate compared with 54.8% PFS rate with ibrutinib. PFS favored zanubrutinib across all subgroups. The overall response rate (ORR) also remained higher with zanubrutinib compared with ibrutinib (90.2% vs 82.8%, respectively). Furthermore, complete remission/incomplete count recovery rates were 10.4% with zanubrutinib and 7.1% with ibrutinib.

To date, ALPINE is the only randomized trial to directly compare 2 Bruton tyrosine kinase (BTK) inhibitors. Overall survival (OS) data did not reach statistical significance but showed fewer deaths.¹

Data From Several Trials on Ibrutinib/ Venetoclax Combination Treatment in Patients With CLL

The fixed-duration combination of ibrutinib and venetoclax (Venclexta; AbbVie Inc) in previously untreated patients with CLL has shown that at 54 months, 82% of patients do not require next-line treatment, according to findings from the phase 2 Captivate trial (NCT02910583). Janssen Research & Development, LLC, also announced new long-term follow-up data from the phase 3 GLOW trial (NCT03462719), which demonstrated an estimated 84.5% OS rate at 54 months among older patients and/or patients with comorbidity with previously unmanaged CLL compared with 63.7% for patients treated with chlorambucil (Leukeran; Aspen Global Inc) plus obinutuzumab (Gazyva; Genentech). The fixed duration of treatment is 12 months.^2,3

Measuring minimal residual disease (MRD) in patients with CLL who were previously untreated was a planned interim analysis of the phase 3 FLAIR trial (ISRCTN01844152). At a median follow-up of 43.7 months, 97.2% of patients in the ibrutinib/venetoclax arm had progression-free disease vs 76.8% of patients receiving FCR (fludarabine [Fludara; Bayer HealthCare Pharmaceuticals], cyclophosphamide, rituximab [Rituxan; Genentech]). Patients with unmutated IGHV region gene fared even better (98.3%). OS was significantly improved compared with FCR as well. Once they achieved MRD negativity, patients in the combination arm had a doubling of treatment time (2-6 years).⁴

CAR T-Cell Drug in Second Line for High-Risk Follicular Lymphoma and in R/R CLL

The first disclosure of primary analysis results from the second-line cohort with high-risk disease in the TRANSCEND FL trial (NCT04245839), an open-label, global, multicenter, phase 2, single-arm study evaluating lisocabtagene maraleucel (liso-cel, Breyanzi; Bristol Myers Squibb) in patients with R/R follicular lymphoma (FL), were presented. Additionally, longterm (24-month) data evaluating liso-cel in patients with R/R CLL/SLL were presented from the phase 1/2 TRANSCEND-CLL-004 study (NCT03331198). Findings from TRANSCEND FL trial, with a median follow-up of 18.1 months, demonstrated liso-cel elicited significant responses in nearly all patients. The ORR and complete response (CR) rate were 95.7%. The median duration of response (mDOR) and median PFS (mPFS) were not reached (NR) at 16.8 months (median follow-up). A PFS rate of 91.3% at 12 months was presented as well as the probability of patients remaining in response at 12 months, which was 89.8%.

Liso-cel continued to exhibit a manageable and predictable safety profile, with no new safety signals observed and low rates of severe cytokine release syndrome (CRS) and neurologic events (NEs). Any-grade CRS occurred in 52.2% of patients, with no grade 3 or greater CRS reported. Any-grade NEs were reported in 17.4% of patients, with grade 3 NEs occurring in 4.3% of patients and no grade 4/5 NEs reported. All cases of CRS and NEs were managed to resolution.⁵

Nearly a Quarter of Patients With CLL Are Not Receiving BTKi/BCL2i As First-Line Treatment

Results from a study, which included more than 6000 patients with CLL/SLL who had received first-line treatment between January 1, 2020, and June 30, 2023, found that although first-line usage of anti-CD20 therapy and immunotherapy has decreased over time, approximately 15% of patients were still receiving anti-CD20 monotherapy up front and nearly 9% were receiving chemoimmunotherapy up front. Significant groups less likely to receive a BTK inhibitor (BTKi) or a B-cell lymphoma 2 inhibitor (BCL2i) include female patients, patients older than 80 years, patients with poor performance status, or patients not tested for TP53 mutations or 17p deletions.⁶

Multiple Myeloma

Real-World Data Fail to Meet Clinical Trial Experience

A 44% poorer PFS and 75% poorer OS have been seen in patients with multiple myeloma (MM) treated in the real world compared with patients treated in clinical trials, according to a pooled analysis of efficacy vs effectiveness for 7 MM regimens. According to the investigators, inclusivity in trial eligibility/design may help to reduce the variance. The authors also posited that the difference in outcomes is likely because clinical trials often have highly restrictive inclusion and exclusion criteria, frequently offer treatment at academic centers, and have small numbers compared with the real-world population, which often has considerable comorbidities. The presenting team attempted to identify which factors were key to the efficacy-effectiveness difference.²

Addition of Isatuximab Increased MRD Negativity in Patients Newly Diagnosed With MM

Data from the phase 3 IsKia trial (NCT04483739) demonstrated that adding isatuximab (Sarclisa; Sanofi) to the regimen of KRd (carfilzomib [Kyprolis; Amgen], lenalidomide [Revlimid; Celgene], dexamethasone) increased MRD negativity to 45% vs 26% with KRd alone. Before consolidation, MRD negativity was 64% vs 49%, respectively, and post consolidation the results increased to 77% and 67%, respectively. This MRD negativity was superior across all subgroups. Additionally, rates of very good partial response and CR were similar in both groups.⁷

CAR T-Cell Therapy Use Still Supported

The risks and benefits of chimeric antigen receptor (CAR) T-cell therapy were discussed at the conference, with a focus on the high efficacy levels these therapies provide in relation to the recent safety concerns. The generally experienced adverse events (AEs) common to therapy (eg, CRS, infections, hypogammaglobulinemia) were reviewed, and management was discussed pertaining to the importance of close collaboration between the practices and the treatment centers.

The newer, more recently discussed AEs for CAR T-cell therapies were also reviewed and discussed. Delayed parkinsonism has been seen 30 to 90 days after treatment, with patients experiencing a cognitive decline, gait issues, and tremors. T-cell expansion seems to be correlated, so a closer monitoring of levels may be appropriate to anticipate the potential reaction. Secondary T-cell malignant tumors have been reported recently by the FDA. Although the incidence is low and can occur with cancer and cancer therapies, importance was given to at least a 15-year follow-up and monitoring period.⁸

CARTITUDE Updates

Updates to 2 CARTITUDE trials evaluating ciltacabtagene autoleucel (cilta-cel, Carvykti; Janssen Biotech Inc) were presented. Findings from the phase 3 CARTITUDE-4 trial (NCT04181827) demonstrated clinically meaningful reductions in disease-specific symptoms and an improvement in health-related quality of life (QOL) measurements, including fatigue, pain, and emotional functioning. The median time of symptom worsening was 23.7 months vs 18.9 months on standardof- care (SOC) therapy. Findings from the phase 2 CARTITUDE-2 trial (NCT04133636) showed that at a median follow-up of 29 months, patients treated with cilta-cel had an ORR of 95% and an mPFS that was NR.⁹

Addition of Daratumumab to SOC Increases PFS in Newly Diagnosed ASCT-Eligible MM

The phase 3 Perseus trial (NCT03710603) included 709 autologous stem cell transplant (ASCT)-eligible patients who received either VRd (bortezomib [Velcade; Takeda], lenalidomide, dexamethasone) or D-VRd (daratumumab [Darzalex; Janssen Biotech Inc] plus VRd). At 47.5 months, PFS rate was 84.3% in the D-VRd arm vs 67.7% in the VRd arm. CR rate was 87.9% vs 70.1%, respectively. The most significant data presented involved MRD negativity: The D-VRd MRD negativity rate was 75.2% vs 47.5% in the VRd arm. Severe treatment-related AEs occurred in 57% of patients who received D-VRd compared with 49.3% who received standard treatment; however, no new AEs were observed that had not been previously observed with daratumumab or VRd.¹⁰

Lymphomas

Bispecific Antibody Long-Term Data Follow-Up for Heavily Premanaged Lymphoma

Investigators of 2 pivotal phase 2 studies, the NP30179 study (NCT03075696) and the GO29781 study (NCT02500407), presented 32-month and 3-year follow-up data, respectively, on fixed-duration treatments of glofitamab-gxbm (Columvi; Genentech) and mosunetuzumab-axgb (Lunsumio; Genentech), respectively. Data from the trials show that remissions were maintained in most patients with heavily premanaged lymphomas.

Additionally, new early-phase data of the combination regimens support ongoing investigation in phase 3 studies in earlier lines for diffuse large B-cell lymphoma (DLBCL) and FL. After a median follow-up of 32 months, findings from NP30179 reported 55% of patients with a CR were in remission at 24 months. Most of these patients remained progression free and alive 18 months after completing the fixed-duration treatment. In patients who had received prior CAR T-cell therapy, the median duration of CR was 22 months. No new safety signals were observed since the previous analysis.

Data from the 3-year follow-up analysis of the GO29781 study of mosunetuzumab-axgb in patients with R/R FL who had received at least 2 prior lines of therapy also were presented. Results showed continued durable responses after treatment, with 59% of patients completing treatment after 8 cycles. Data showed that 72.7% of patients with a CR were alive and without disease progression 30 months after their first response. mPFS was 24 months, and OS was NR. No new safety signals were observed since the previous analysis.¹¹

ASCT vs CAR T-Cell Therapy Outcome Measurement in Relapsed DLBCL

Results from a new study based on data from the world’s largest database of patients treated with stem cell transplants, CAR T-cell therapy, and similar therapies found that when patients in complete remission received high-dose chemotherapy plus an autologous transplant, they had fewer second relapses and their cancer stayed in remission for a longer time compared with similar patients who received CAR T-cell therapy. Two years after treatment, 27.8% of patients treated with ASCT experienced another relapse compared with 48% of those treated with CAR T-cell therapy. For the current study, the researchers compared outcomes for 360 adult patients with relapsed DLBCL who received either CAR T-cell therapy or ASCT while in complete remission. The study’s primary end points were PFS and OS. The ASCT group had longer remissions and lived longer than those in the CAR T-cell therapy group (PFS rate of 66.2% and OS rate of 78.9% in the ASCT group vs PFS rate of 47.8% and OS rate of 65.6% in the CAR T-cell therapy group).¹²

Nivolumab-AVD vs Bv-AVD in Older Patients With Advanced-Stage Hodgkin Lymphoma

Results from the phase 3 SWOG S1826 study (NCT03907488), which compared nivolumab (Opdivo; Bristol Myers Squibb) vs brentuximab vedotin (Bv, Adcetris; Seagen), both in combination with AVD (doxorubicin, vinblastine [Velban; Avalon Pharma], dacarbazine [DTIC-Dome; Bayer HealthCare Pharmaceuticals]), in older patients with advanced Hodgkin lymphoma, were presented. At 1 year, the event-free survival (EFS) rate was 93% vs 57%, PFS rate was 93% vs 64%, and OS rate was 95% vs 83% for nivolumab and Bv, respectively. The nonrelapse mortality rate was 4% and 14%, respectively. Follow-up is ongoing to assess long-term safety, PFS durability, OS, and patient-reported outcomes.¹³

JAK1 Inhibitor Shows Promise in Peripheral T-Cell Lymphoma

Phase 2 JACKPOT8 trial (NCT04105010) data were presented for the JAK1 inhibitor golidocitinib (DZD4205; Dizal Pharmaceutical) in peripheral T-cell lymphoma (PTCL). In total, 88 patients with R/R PTCL who had received a median of 2 prior lines of therapies were included in the analysis. Trial findings showed that 39 patients responded to golidocitinib achieving tumor response with an ORR of 44.3% (95% CI, 33.7%-55.3%), with 21 patients (23.9%) achieving CR. The responses were durable, lasting more than 20 months at median, with more than half of patients still responding after a median follow-up of 12.5 months. Furthermore, 52.3% of patients were still alive at the data cutoff, with a median OS (mOS) of 19.4 months vs 6 to 8 months of survival benefit with standard treatment.¹⁴

EZH1/2 Inhibitor Demonstrates Efficacy in R/R PTCL

Findings from the phase 2 VALENTINE-PTCL01 trial (NCT04703192) reported valemetostat (Ezharmia; Daiichi-Sankyo) showed an ORR (via computed tomography) of 43.7% and a CR rate of 14.3%. Patients had a median age of 69 years and a median of 2 prior lines of therapy. mDOR was 11.9 months, mPFS was 5.5 months, and mOS was 17 months.¹⁵

Long-Term Axicabtagene Ciloleucel Data Presented Across Multiple Trials

Three follow-up analyses investigating axicabtagene ciloleucel (Yescarta; Kite Pharma Inc) were presented at the 65th ASH Annual Meeting & Exposition. In findings from the phase 1/2 ZUMA-1 trial (NCT02348216) investigating axicabtagene ciloleucel in patients with R/R LBCL, at a 6-year follow-up, the 5-year lymphomarelated EFS rate was 34% and mOS was 25.8 months. Furthermore, patients who had a CR had a 72-month disease-free survival rate between 94.4% and 100%.

In the phase 2 ZUMA-5 trial (NCT03105336) investigating axicabtagene ciloleucel in patients with R/R indolent non-Hodgkin lymphoma (iNHL), FL, and marginal zone lymphoma (MZL), data showed that at a median follow-up of 52.5 months, ORR was 90% with a 75% CR rate. For patients with iNHL, mDOR was 55.5 months. Patients with FL had an mDOR of 55.5 months, and patients with MZL had an mDOR that was NR.

In the phase 3 ZUMA-7 trial (NCT03391466), patients were included who had refractory LBCL, with investigators assessing axicabtagene ciloleucel vs SOC. At a median follow-up of 46.6 months, OS and PFS were significantly increased vs SOC in the age groups for patients older than 65 years and patients older than 70 years. OS was 43.5 months (age > 65 years) and 24.7 months (age > 70 years) vs 19.5 months (age > 65 years) and 11.2 months (age > 70 years), respectively. PFS was 28.6 months (age > 65 years) and 11.4 months (age > 70 years) vs 5 months (age > 65 years) and 2.7 months (age > 70 years), respectively.¹⁶

Ibrutinib/Venetoclax Combination Shows Increased PFS in Mantle Cell Lymphoma

Results from the phase 3 SYMPATICO trial (NCT03112174) were presented, demonstrating an mPFS of 31.9 months in patients treated with the combination of ibrutinib and venetoclax vs 22.1 months in the ibrutinib/placebo arm. The CR rate was 54% for the combination treatment vs 32% in the ibrutinib arm. The median time to next treatment was NR vs 35.4 months, respectively. An increase of OS was seen but was deemed not statistically significant.¹⁷

Circulating Tumor DNA Testing to Guide Treatment Options in Newly Diagnosed Lymphoma

A phase 2 trial (NCT04980222) looked to determine whether analyzing circulating tumor DNA (ctDNA) can help clinicians decide whether adding the bispecific antibody glofitamab to the combination therapy of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone) may add benefit as first-line therapy. Patients who were determined to have high risk of recurrent disease (< 100-fold ctDNA reduction after 1 cycle) were given glofitamab plus R-CHOP. Data presented showed a 95% ORR and a complete metabolic response rate of 60%, which increased to 85% by treatment end.18

Acute Myeloid Leukemia/CML

Tuspetinib for R/R AML

Tuspetinib (Aptose Biosciences), a multikinase inhibitor that suppresses SYK, FLT3, mutated KIT, JAK1/2, RSK2, and MCL1, is demonstrating efficacy and safety in patients with acute myeloid leukemia (AML) either alone or in combination with venetoclax. Composite complete remission (CCR) rate was 13% overall in the tuspetinib-alone arm and higher in venetoclaxnaive patients and patients with FLT3 mutations. In combination with venetoclax, the overall CCR rate was 25%, with higher percentages in patients who were venetoclax naive or had FLT3 mutations.¹⁹

MRD as a Predictor of Allogeneic Transplant Benefit in NPM1-Mutated AML

In findings from an analysis of the phase 3 AML17 (ISRCTN55675535) and AML19 (ISRCTN78449203) studies, patients who had MRD positivity had improved survival when they received an allogeneic stem cell transplant, whereas among patients who had MRD negativity, researchers could not identify any subgroup that showed a survival benefit from a transplant at 3 years. In findings from these trials, among patients with MRD negativity, 3-year OS rate was 75% for those enrolled in AML17 and 83% for those in AML19. Undergoing a donor transplant did not further improve survival for patients who had MRD negativity. By contrast, 3-year OS rate among patients with MRD positivity who underwent a donor transplant was 61% compared with 24% for those who did not receive a donor transplant.⁷

Phase 2 Trial Findings Report Efficacy of Reduced-Dose Ponatinib for Chronic Myelogenous Leukemia Induction

The phase 2 TIPI trial (NCT04070443) is testing 6 months of ponatinib (Iclusig; ARIAD Pharmaceuticals) at 30 mg daily as induction therapy followed by imatinib (Gleevec; Novartis) at 400 mg daily until treatmentfree remission in patients with chronic myelogenous leukemia (CML). At 1 month, 93% of patients had a complete hematologic response and 97% had an early molecular response. At 3 months, 70.5% had a complete cytogenetic response. Major molecular response rate was 57% at 6 months, and the 6-month EFS rate was 90.53%.²⁰

Data for Investigational Oral Drug for Acute Leukemia Presented

Revumenib, an oral menin inhibitor, showed an ORR of 63% and a CR rate of 23% in R/R KMT2A-rearranged acute leukemias. Among the CR responders, 70% attained MRD negativity and the median duration of remission was 6 months. Furthermore, 40% of responders were able to receive ASCT. mOS was 8 months.²¹

Myelofibrosis/Myeloproliferative Neoplasms/Myelodysplastic Syndromes

Combination Targeted Therapy for Myelofibrosis

Combining navitoclax (ABT-263; AbbVie Inc) and ruxolitinib (Jakafi; Incyte) is the basis of the TRANSFORM trial (NCT03575351). The phase 3 TRANSFORM trial is a randomized, double-blind, placebo-controlled, multicenter, international study of navitoclax in combination with ruxolitinib vs ruxolitinib plus placebo in patients with unmanaged myelofibrosis. After a median follow-up of 14.9 months, 63.2% of patients in the navitoclax plus ruxolitinib group had achieved a statistically significant reduction of at least 35% in spleen enlargement at week 24 compared with 31.5% in the placebo plus ruxolitinib group. At week 24, the average change in the total symptom score was not statistically significant. The most common AEs included low blood cell counts and diarrhea. A total of 33% of patients discontinued the study treatment, with the most common reason for discontinuation being AEs.⁷

Tyrosine Kinase Inhibitor in Myelofibrosis Demonstrates Efficacy in MDS/MPN

Findings from a clinical trial (NCT05177211) showed that fedratinib (Inrebic; Bristol Myers Squibb) demonstrated activity in patients with myelodysplastic syndromes (MDSs)/ myeloproliferative neoplasms (MPNs). In the trial, the cohort included 4 patients with MDSs/MPNs with ring sideroblasts and thrombocytosis, 4 who had chronic neutrophilic leukemia, 2 who had atypical CML, and 1 who had an unclassifiable MDS/MPN. At 12 and 24 weeks, the ORR was 36% and 62.5%, respectively. At the median time of 7.6 months, the mOS had not been reached.¹²

Sickle Cell Disease

Near-Complete Pain Resolution for Patients With Sickle Cell Disease

Lovotibeglogene autotemcel (lovo-cel, Lyfgenia; Bluebird Bio Inc) as a single treatment achieved near-complete resolution of severe pain crises in patients with sickle cell disease in a presented analysis. Of 34 evaluable patients, 88.2% achieved complete resolution of all vaso-occlusive events (VOEs) and 94.1% experienced complete resolution of severe VOEs during a 6- to 18-month assessment period following infusion. Patients who experienced any kind of acute pain event or VOE post treatment experienced a reduction of at least 50% compared with baseline as well as a reduction in hospital admissions (from 2.5 to 0.4) and days in hospital (from 15.75 to 2.20). Lovo-cel also demonstrated efficacy in younger patients, with all 10 adolescents (≥ 12 years to < 18 years) in the study experiencing a complete resolution of VOEs during the assessment period.

Lovo-cel demonstrated durable therapy, with all patients maintaining a stable hemoglobin level from 6 months to the last follow-up, with some maintaining that level up to 60 months. Approximately 87% of patients achieved a globin response, with all those patients maintaining that response through the last follow-up. Effectiveness was also demonstrated by QOL results, with clinically meaningful improvements in pain intensity, pain interference, and fatigue reported in 57%, 64%, and 64% of patients, respectively. Most AEs occurred within 1 year of lovo-cel infusion and were consistent with AEs exhibited with busulfan conditioning. Two patients had lovo-cel–related serious AEs.²²

GVHD

High Response Rates Seen With Axatilimab in Chronic Disease

Data from the phase 2 AGAVE-201 trial (NCT04710576) demonstrated the anti-colony stimulating factor 1 receptor monoclonal antibody axatilimab-csfr (Niktimvo, Incyte Corporation) had an ORR of 74% at the lowest dose administered in graft-vshost disease. Furthermore, 60% of patients maintained a response for at least 12 months. Median failure-free survival was 17.3 months, with 55% of patients reporting clinically meaningful symptom burden reduction. CRs were seen across all organ types.^23,24

References

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3. New data presented at ASH from the phase 3 GLOW study show fixed-duration, first-line treatment with IMBRUVICA (ibrutinib) plus venetoclax demonstrated an overall survival rate of more than 84 percent at 54 months in patients with chronic lymphocytic leukaemia. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. December 11, 2023. Accessed December 11, 2023. https://www.obroncology.com/news/new-data-presented-at-ash-from-the-phase-3-glow-study-show-fixed-duration

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17. Ehlers J. Fedratinib elicits responses, improves symptoms in MDS and MPNs. Cancer Therapy Advisor. December 9, 2023. Accessed December 11, 2023. https://www.cancertherapyadvisor.com/home/news/conference-coverage/american-society-of-hematology-ash/ash-2023/myelodysplastic-mds-mpn-fedratinib-response-improves-symptoms/

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19. Ehlers J. Tuspetinib alone or in combo has shown activity in relapsed/refractory AML. Cancer Therapy Advisor. December 10, 2023. Accessed December 11, 2023. https://www.cancertherapyadvisor.com/home/news/conference-coverage/american-society-of-hematology-ash/ash-2023/tuspetinib-aml-alone-combo-activity/

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About the Author

Douglas Braun, PharmD, CSP, RPh, is a senior pharmacy director at the American Oncology Network, LLC, in Naples, Florida.