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Final analysis of SGNTUC-019 showed a 41.9% ORR, an 80.6% DCR, and a 18.2-month DOR with tucatinib/trastuzumab in pretreated, HER2-mutated metastatic breast cancer.

Tucatinib/Trastuzumab Yields Durable Responses in HER2-Mutated Metastatic Breast Cancer

T-DM1 plus palbociclib showed significant PFS in patients with HER2-positive metastatic breast cancer.

T-DM1 Plus Palbociclib Displays Activity in HER2+ Metastatic Breast Cancer  

EL1SSAR data reinforce the importance of PD-L1 assessment to select patients with TNBC with the best outcomes on atezolizumab.

EL1SSAR Data Shed Light on Leveraging Atezolizumab Plus Nab-Paclitaxel in PD-L1+ TNBC

Baseline ctDNA concentration was shown to be the most significant predictor of distant recurrence-free survival in patients with early breast cancer.

Pretreatment ctDNA Status Is Associated With Distant Recurrent-Free Survival in Early Breast Cancer 

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 as an assistant editor in October 2022. Leveraging an educational background in the life sciences and prior experience conducting interviews in a university setting, she plays a key role in shaping social media strategy, covering live conferences, and producing multimedia content for both print and digital platforms. Email: 

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 in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: chryan@onclive.com

The DLL3-targeted antibody-drug conjugate ZL-1310 has received FDA fast track designation for patients with extensive-stage small cell lung cancer.

FDA Grants Fast Track Designation to DLL3-Targeted ADC ZL-1310 in ES-SCLC

Two belantamab mafodotin–based combinations have been approved in Japan for relapsed/refractory multiple myeloma.

Belantamab Mafodotin–Based Combos Win Japanese Approval for R/R Myeloma

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as well as news and conference updates for OncLive.com. Email: kdoherty@mjhlifesciences.com

During an OncLive Peer Exchange filmed during ASCO GU, expert investigators discussed significant updates in the RCC space.

Combination Regimens Offer Options in Frontline RCC as Novel Agents Advance Through Pipeline

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. A recent College of New Jersey graduate, Jax majored in Journalism/ Professional Writing with minors in Public Health and Anthropology. He is also pursuing a Master's Degree in Public Health, concentrating on health communications.

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As genetic testing becomes increasingly available,
there will be a growing gap between
the wide availability of testing and the relative
importance of results to treatment decisions.

How Genetic Testing Impacts Breast Cancer Treatment Decisions

In The incorporation of CDK4/6 inhibitors into the adjuvant treatment of patients with hormone receptor (HR)–positive, HER2-negative early-stage breast cancer has introduced an additional strategy to reduce recurrence risk following standard multimodal therapy, according to Arielle Heeke, MD, who noted that the recent addition of ribociclib (Kisqali) to the adjuvant treatment arsenal has broadened the applicability of this approach.

FDA approved abemaciclib (Verzenio) in combination with endocrine therapy

 for the treatment of patients with HR-positive, HER2-negative, early-stage breast cancer at high risk of recurrence and a Ki67 score of 20% or greater based on results from the phase 3 monarchE trial (NCT03155997).

 in March removed the Ki-67 score requirement for patient selection.

FDA approved ribociclib plus an aromatase inhibitor (AI)

for the treatment of patients with HR-positive, HER2-negative stage II/III early breast cancer at high risk of recurrence, based on data from the phase 3 NATALEE (NCT03701334).

“CDK4/6 inhibitors can be prescribed to patients with stage II or [higher] breast cancer, and the data are strong for both [abemaciclib and ribociclib]. [Accordingly, selecting between these agents] can be based on patient and/or provider preference,” Heeke said during an interview with 

® following a State of the Science Summit™ on breast cancers. “Over time, [however], we will probably lean into [using] ribociclib in the non-metastatic setting.”

In the interview, Heeke highlighted the role of CDK4/6 inhibitors in the HR-positive, HER2-negative, early-stage breast cancer treatment paradigm; key clinical considerations when choosing between abemaciclib and ribociclib; and how the FDA approval of the PARP inhibitor olaparib (Lynparza) has improved the treatment arsenal in this space.

Heeke is a clinical associate professor in the Department of Hematology and Oncology at Wake Forest University School of Medicine and a physician at Atrium Health Levine Cancer Institute in North Carolina.

: How have CDK4/6 inhibitors in the adjuvant setting changed the treatment paradigm for patients with HR-positive, HER2-negative early-stage breast cancer?

 [This is] a tough diagnosis to get, [although] patients [with this disease] have [many] treatment options. There’s potentially chemotherapy, obviously surgery and radiation, endocrine therapy for 5 to 10 years, ovarian suppression, and now CDK4/6 inhibitors. We are using them a lot because they're helpful, especially when you have somebody that, at the end of all that other [treatment], still has a high risk of recurrence. [For example, if they have a risk of recurrence of] 30%, and they're interested in [receiving CDK4/6 inhibitors,] that could reduce approximately 7% of their risk. However, it doesn't take the risk of recurrence down to 0%, which is the tough thing. We wish we could promise people that, but a 30% or even 20% risk of recurrence after completion of their other therapies is uncomfortably high. Therefore, if they can get it down closer to 10%, it's often worth it to the patient.

We're lucky to have 2 [CDK 4/6 inhibitors] now. Abemaciclib is helpful because it's only [taken for] 2 years. The data [showing its efficacy] are strong, but the control arms are a little different. Ribociclib is generally a little easier to tolerate. In practice, I recommend CDK4/6 inhibitors for patients with lymph node–positive disease. The NATALEE study has certainly challenged that a little bit, because it's available for lymph node–negative disease as well. [That study has] shown that all subgroups were benefiting similarly from the addition of ribociclib to [endocrine therapy], which speaks to how we don't know exactly [which] patients need the therapy. It could be in both groups. Personally, I hope that circulating tumor DNA will help us better select [the appropriate patient population].

What are some key clinical considerations when selecting CDK4/6 inhibitors for your patients?

When ribociclib was FDA approved [for this indication], I was still more fond of the abemaciclib, just because the absolute benefit seemed greater. We had gotten comfortable with patients taking it already and although it wasn't necessarily the most fun [treatment], patients were [taking it] and getting through the 2 years [of treatment]. With it, I wasn't admitting people to the hospital because of horrible diarrhea or any [adverse effects] like that. It was a quality-of-life damper, but the patients were getting through it okay. Now that I've [come to know] the data a little bit better between monarchE and NATALEE and have a better understanding of the calculated differences in the experimental and control arms, with patients in the control arm on NATALEE doing better, I'm feeling much more comfortable leaning into ribociclib. The only caveat there is the 3-year treatment duration—I haven't had that experience of trying to keep somebody on therapy for the full 3 years. However, in terms of tolerance of the patients that I've put on the ribociclib in the adjuvant setting, they seem to tolerate it better than when we put them on adjuvant abemaciclib. In the metastatic setting, the 600 mg dose of ribociclib is challenging. People do struggle with fatigue and cytopenias, but the 400 mg [dose] is generally well tolerated.

How has the addition of olaparib (Lynparza) to the treatment toolbox in 

-mutated, high-risk early breast cancer improved patient outcomes?

First, there aren’t that many patients with 

 mutations. Second, they have to be high risk. Patients were mostly undergoing some sort of therapy before surgery. For [patients with] triple-negative breast cancer, for example, they must have residual disease. Now, with our 5-drug immunotherapy regimen, approximately 35% of patients are going to have residual disease. Within that 35%, how many are going to be 

 mutation carriers? It’s a pretty uncommon mutation. For patients with HR-positive disease, they must have multiple lymph nodes involved.

I've only had 3 patients who have been eligible [for olaparib and] whom I've given the drug to, and it was fairly well tolerated. My patients all have been bummed about it because by the time they get done the chemotherapy and surgery, it's already been a long journey, and then they have [to undergo] another year of therapy. They just didn't quite expect that. However, mechanistically, we believe in the value of olaparib for their specific needs.

FDA approves abemaciclib with endocrine therapy for early breast cancer. FDA. Updated October 13, 2021. Accessed April 30, 2025. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-endocrine-therapy-early-breast-cancer

US FDA broadens indication for Verzenio (abemaciclib) in HR+, HER2-, node-positive, high risk early breast cancer. News release. Eli Lilly and Company. March 3, 2023. Accessed May 2, 2025. 

https://investor.lilly.com/news-releases/news-release-details/

FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer. FDA. September 17, 2024. Accessed April 30, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ribociclib-aromatase-inhibitor-and-ribociclib-and-letrozole-co-pack-early-high-risk

Arielle Heeke, MD, highlights the role of adjuvant abemaciclib and ribociclib in patients with HR-positive, HER2-negative, early breast cancer.

Clinical

Adjuvant CDK4/6 Inhibition Gains Further Ground in HR+/HER2– Early Breast Cancer With Ribociclib Approval

All-oral doublet regimens (eg, acalabrutinib plus venetoclax) are extremely exciting to the field of chronic lymphocytic leukemia (CLL), as many patients prefer oral-only therapies. However, identifying ideal patients to receive doublet versus triplet versus continuous Bruton tyrosine kinase inhibitor (BTKi) monotherapy in the first-line setting is still evolving.

Treatment sequencing in CLL will become increasingly more difficult with new combination regimens becoming more widely used in the first-line setting.

The optimal sequencing of BTK inhibitors and chimeric antigen receptor T-cell therapy (CAR-T) is still being debated.

Bispecific antibodies and BTK degraders remain exciting emerging therapies in the relapsed and/or refractory CLL population.

The faculty expressed enthusiasm for all-oral doublet regimens such as AV (acalabrutinib plus venetoclax), which have already been included in NCCN guidelines. However, distinguishing which patients would benefit most from AV versus currently available therapies like VEN+O (venetoclax plus obinutuzumab) remains difficult in the absence of data from direct comparative trials.

Clinicians continue to debate about first-line triplet therapies, as they are concerned about high infection rates and cytopenias. They were excited about the data with pirtobrutinib plus VEN+O from the American Society of Hematology (ASH) 2024 conference. Another emerging combination includes AVO (AV plus obinutuzumab) in high-risk patients from a phase two study lead by

 as the AMPLIFY trial excluded patients with 

aberration. The faculty agreed that selecting the appropriate patient for these novel combination regimens is an ongoing discussion.

Treatment Sequencing in CLL: Second-Line Treatment Options

Faculty members largely agreed that acalabrutinib and zanubrutinib are comparable in the second-line setting for those who received fixed-duration therapy in the first-line setting. The faculty largely agreed that the ideal time window of retreatment with venetoclax is still debatable, but 1 year of progression- free survival with VEN+O would be too short for such consideration. With new combination therapies (eg, AV and/or AVO) most likely getting approved soon, sequencing of therapies will be complicated, and analyzing durability of responses will be increasingly important.


Overall, the faculty agree that pirtobrutinib is a well-tolerated agent. However, the ideal role of pirtobrutinib in R/R CLL as a second-line versus third-line treatment remains debated. There is debate on the utility of the control arm of the phase three trial that was presented at ASH 2024 (BRUIN CLL-321), with some experts no longer viewing BR (bendamustine plus rituximab) or IdelaR (idelalisib plus rituximab) as a standard of care.

Managing R/R CLL After BTKi- and Venetoclax-Containing Regimens

The discussion on R/R CLL highlighted the lack of consensus regarding optimal sequencing after receiving both covalent BTKi and venetoclax-containing regimens. Faculty members expressed mixed opinions on the efficacy of CAR-T in CLL. Some cited promising long-term remission rates; others noted the difficulty in selecting appropriate candidates, as the majority of the CLL population are elderly and may not tolerate CAR-T.

Emerging treatments such as bispecific antibodies (eg, epcoritamab) and BTK degraders were highlighted as potential game-changers in CLL management. Faculty members noted that bispecific antibodies may be an alternative to CAR-T particularly given the logistical challenges of CAR-T manufacturing and administration. The faculty acknowledged that the durability of responses of these novel therapies must be understood, as those data are being gathered.

The increasing treatment options available make this an exciting time for CLL treatment; however, it also is a more challenging time, since it is unclear who are the most ideal candidates for doublet or triplet therapies in the frontline setting. The faculty agree that there are multiple treatment approaches in the high-risk population. These include minimal residual disease testing to decide to discontinue or de-escalate therapy; however, this is primarily done in the clinical trial setting.

The faculty agree that the ideal role of BTK inhibitors and CAR-T must be understood further, and strategies to improve durability of responses in the relapsed and/or refractory population must be the focus.

Head-to-head clinical trials comparing novel combination regimens, such as AV versus Ven+O, are necessary to guide treatment selection. Furthermore, optimizing sequencing strategies after use of doublet or triplet regimens remains a gray area, as the durability of responses is unknown for this patient population. Long-term follow-up studies and real-world data for novel or investigational therapies are critical to understanding their optimal use.

The discussion underscores the rapidly evolving CLL landscape and the importance of continued research to refine sequencing strategies and to individualize treatment selection. The faculty largely agree on treatment strategies for a “typical” CLL patient, although differing opinions on pirtobrutinib’s role and CAR-T sequencing highlight ongoing debates in the field. As novel therapies continue to emerge, their integration into a treatment paradigm that optimizes patient outcomes while minimizing toxicity will remain a challenge.

Clinical Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

, Version 2.2025. Accessed February 19, 2025. 

https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf

Brown JR, Seymour JF, Jurczak W, et al. Fixed-duration acalabrutinib plus venetoclax with or without obinutuzumab versus chemoimmunotherapy for first-line treatment of chronic lymphocytic leukemia: interim analysis of the multicenter, open-label, randomized, phase 3 AMPLIFY trial. 

. 2024;144(suppl 1):1009. doi:10.1182/blood-2024-200701

Jain N, Ferrajoli A, Swaminathan M, et al. Combined pirtobrutinib, venetoclax, and obinutuzumab as first-line treatment of chronic lymphocytic leukemia. 

. 2024;144(suppl 1):1011. doi:10.1182/blood-2024-211454

Davids MS, Ryan CE, Lampson BL, et al. Phase II study of acalabrutinib, venetoclax, and obinutuzumab in a treatment-naïve chronic lymphocytic leukemia population enriched for high-risk disease. 

. Published online December 7, 2024. doi:10.1200/JCO-24-02503

Sharman JP, Munir T, Grosicki S, et al. BRUIN CLL-321: randomized phase III trial of pirtobrutinib versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma. 

. 2024;144(suppl 1):886. doi:10.1182/blood-2024-198147

Siddiqi T, Gauthier J, Kenderian SS, et al. Lisocabtagene maraleucel (liso-cel) in patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL): updated follow-up of Transcend CLL 004. 

. 2024;144(suppl 1):4633. doi:10.1182/blood-2024-200840

Wierda WG, Dorritie K, Gauthier J, et al. Lisocabtagene maraleucel (liso-cel) combined with ibrutinib (ibr) for patients (pts) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): primary results from the open-label, phase 1/2 Transcend CLL 004 study. 

. 2024;144(suppl 1):887. doi:10.1182/blood-2024-200339

Frost BF, Frey N, Hexner EO, et al. Curing CLL: long-term outcomes of chronic lymphocytic leukemia patients with at least one year of response to CART-19 therapy. Blood. 2024;144(suppl 1):588. doi:10.1182/blood-2024-204197

Danilov A, Fakhri B, Awan FT, et al. Epcoritamab monotherapy in patients (pts) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL): results from CLL expansion and optimization cohorts of Epcore CLL-1. 

. 2024;144(suppl 1):883. doi:10.1182/blood-2024-199708

Shah NN, Omer Z, Collins GP, et al. Efficacy and safety of the Bruton's tyrosine kinase (BTK) degrader NX-5948 in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): updated results from an ongoing phase 1a/b study. 

. 2024;144(suppl 1):884. doi:10.1182/blood-2023-194839

Thompson MC, Parrondo RD, Frustaci AM, et al. Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: results from the phase 1 CaDAnCe-101 study. 

. 2024;144(suppl 1):885. doi:10.1182/blood-2024-199116

The landscape of chronic lymphocytic leukemia (CLL) treatment is rapidly evolving with the introduction of all-oral doublet regimens, such as acalabrutinib plus venetoclax, and emerging therapies like bispecific antibodies and BTK degraders. The optimal sequencing of these therapies, including BTK inhibitors and CAR-T, remains a topic of debate. Clinicians face challenges in selecting appropriate patients for novel combination regimens and determining the ideal sequencing strategy. Continued research and head-to-head clinical trials are essential to refine treatment strategies and improve patient outcomes.

On February 13, 2025, a select group of experts in chronic lymphocytic leukemia (CLL) participated in a virtual workshop to discuss the evolving treatment landscape of CLL and discussed subjects ranging from treatment of newly diagnosed patients to therapies for those relapsed/refractory (R/R) disease. Moderated by Alexey V. Danilov, MD, PhD, the discussion covered insights into emerging treatment approaches, novel therapeutic strategies, and sequencing of available therapies to optimize patient outcomes.

This article was supported in part by Eli Lilly. Content independently developed and published by OncLive.

Scientific Interchange & Workshop

Bridging Data and Expert Insights: Paving the Way for Improved CLL Outcomes

Núria Agustí Garcia, MD, discusses patient eligibility in a cohort study assessing adjuvant chemoradiotherapy vs radiotherapy alone in patients with cervical cancer.

Dr Agustí Garcia on Patient Eligibility for Evaluating Chemoradiotherapy vs Radiotherapy Alone in Intermediate-Risk Cervical Cancer

“[In this study,] we included patients who have undergone radical hysterectomy with negative lymph nodes, and we divided the population based on whether they received radiotherapy alone vs chemoradiation.”

Núria Agustí, MD, a postdoctoral fellow at MD Anderson Cancer Center, discussed the patient population included in a cohort study evaluating adjuvant chemoradiotherapy vs radiotherapy alone in the treatment of intermediate-risk cervical cancer.

The study used data retrieved from the National Cancer Database between 2010 and 2020, Agustí Garcia began. She emphasized that data prior to 2010 were not included because there were no values for lymphovascular space invasion (LVSI), and there also wasn’t information on surgical approaches. These variables could directly affect primary outcomes, which is largely why prior data were excluded, she explained.

The patient population included those with cervical cancer who underwent radical hysterectomy with negative lymph nodes and were stratified based on whether they had received adjuvant chemoradiotherapy or radiotherapy alone, Agustí noted. Patients not included on the study had high-risk disease factors, such as positive margins, parametrial extension, and positive lymph nodes. Furthermore, the Sedlis criteria for the study included the intermediate-risk group of patients with cervical cancer, Agustí said. For missing values, multiple imputation allowed for a more accurate representation of the patient population, she added. After imputation, the propensity score was matched 1:1 to control the cofounders related to clinical, pathologic, and demographic variables to have a well balanced population, she said.

Of note, a total of 1116 patients were identified ,and 43.5% had received concurrent chemoradiotherapy, according to the findings from the study published in 

. Patients with adenocarcinoma or adenosquamous histology more commonly received chemotherapy compared with those with squamous cell carcinoma (risk ratio [RR]; 12.6; 95% CI, 1.10-1.44) and those with tumors larger than 4 cm vs tumors less than 4 cm (RR, 1.31; 95% CI, 1.14-1.51).

In the study, a subgroup analysis was also performed based on 5 variables that could affect the primary outcome of survival, based on prior evidence, Agustí noted. She concluded that these variables included the LVSI, tumor size, histology, surgical approach, and radiotherapy use.

The study also evaluated the potential association of unmeasured confounders using the E-value, a sensitivity analysis that quantified the strength of association an unmeasured confounder must have with the exposure and outcome to explain an observed association. A sensitivity analysis was also performed using a complete case approach and compared the results with those from the fully imputed datasets. 

The results of this cohort study suggested that adding chemotherapy to radiotherapy was not associated with improved overall survival (OS) in patients with intermediate-risk cervical cancer. The subgroup analysis did not show any differences in OS according to the use of chemoradiotherapy or radiotherapy alone.

Núria Agustí, MD, discusses patient eligibility in a cohort study assessing adjuvant chemoradiotherapy vs radiotherapy alone in patients with cervical cancer.

Dr Agustí on Patient Eligibility for Evaluating Chemoradiotherapy vs Radiotherapy Alone in Intermediate-Risk Cervical Cancer

Findings from CALGB (Alliance)/SWOG 80702

Dr. Benjamin Weinberg presents findings from a ctDNA-based analysis of the CALGB/SWOG 80702 trial, showing that circulating tumor DNA status may help identify patients with stage III colon cancer who could benefit from celecoxib added to standard adjuvant chemotherapy, offering a potential biomarker-driven approach to personalized treatment.

Prognostic and Predictive Role of Circulating Tumor DNA (ctDNA) in Stage III Colon Cancer Treated With Celecoxib: Findings from CALGB (Alliance)/SWOG 80702

Genotype-Directed Therapies for HR+/HER2– Advanced Breast Cancer

DISCLAIMER: In the Phase 3 INAVO-120 Study evaluating inavolisib+palbociclib+fulvestrant, the correct PFS data is 15 months vs. 7.3 months, not 24 vs. 15 months as stated; 2) Time to chemotherapy data was not available at primary analysis; 3) The safety profile characterization was incomplete - the treatment showed a low discontinuation rate of only 6% due to adverse events, with grade 3+4 AEs (specific to Rash & Nausea) were 0%.

Video content above is prompted by the following:

What are the more genotype-directed options for advanced HR+/HER2–- disease (PI3K/AKT/mTOR inhibitors, ADCs, etc.) ?

How, and for what patient populations, are these being used based on the most recent data? What are your impressions of each of these regimens?

– How might the recent first-line inavolisib approval change the treatment paradigm? (approved in combination with palbociclib and fulvestrant for patients with

-mutated, HR+, HER2–- la /metastatic breast cancer mBC that who progress on or relapse within 12 months after completing adjuvant endocrine therapy)change the treatment paradigm? 

Panelists discuss genotype-directed treatment options for advanced HR+/HER2– disease, including PI3K/AKT/mTOR inhibitors and antibody-drug conjugates (ADCs), their use based on recent data, impressions of these regimens, and how the recent first-line approval of inavolisib in combination with palbociclib and fulvestrant for PI3K-mutated HR+/HER2– metastatic breast cancer may change the treatment paradigm.

Steven J. Katz, MD, MPH

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