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director of Sarcoma Medical Oncology at the University of Colorado Cancer Center.

Dr. Breelyn Wilky explains that personalized treatments are helping improve outcomes for patients with gastrointestinal stromal tumors.

Personalized Therapy Helps Tailor Treatment for GIST

Among patients with advanced castration-sensitive prostate cancer, health-related quality of life was not statistically different between those receiving Erleada (apalutamide) alone or in combination with Zytiga (abiraterone acetate) and prednisone compared with those receiving androgen-deprivation therapy (ADT) plus Zytiga and prednisone, according to findings in 

Health-related quality of life was evaluated using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) questionnaire and its subscales. The questionnaire was completed at baseline and every four weeks until week 25. FACT-P scores range from 0 to 156, with higher scores indicating better quality of life, according to study authors.

There were no significant differences in baseline mean FACT-P total scores or subscales across the three treatment groups: ADT plus Zytiga and prednisone, 118.5; Erleada, 116.1; and Zytiga and prednisone plus Erleada, 114.9.

Health-related quality of life was maintained during the treatment period, with no statistically significant differences at 25 weeks in mean FACT-P total scores or subscales: ADT plus Zytiga and prednisone, 122.3; Erleada monotherapy, 119.5; and Zytiga and prednisone plus Erleada, 119.9.

The Erleada monotherapy and Zytiga and prednisone plus Erleada groups did not experience meaningful improvements in health-related quality of life compared with the ADT plus Zytiga and prednisone group, except in time to deterioration of the emotional well-being score. This outcome was more favorable in those who received Erleada alone, with a 63% reduction in risk compared with the ADT plus Zytiga and prednisone group, which had a 44% reduction in risk.

A prostate-specific antigen level of 0.2 nanograms per milliliter or lower at week 25 was observed in 31 of 41 patients (75.6%) in the ADT plus Zytiga and prednisone group, 24 of 40 patients (60%) in the Erleada monotherapy group and 31 of 39 patients (79.5%) in the Erleada plus Zytiga and prednisone group. The two-year overall survival rates were 92.5% for the ADT plus Zytiga and prednisone group, 87.9% for the Erleada monotherapy group and 92.7% for the Erleada plus Zytiga and prednisone arm.

Treatment-related side effects of any grade were reported in 30 of 42 patients (71.4%) in the ADT plus Zytiga and prednisone group, 34 of 42 patients (81%) in the Erleada monotherapy group and 36 of 44 patients (81.8%) in the Erleada plus Zytiga and prednisone group.

Grade 3 (severe) and 4 (life-threatening) treatment-related side effects occurred in eight of 42 patients (19%) in the ADT plus Zytiga and prednisone group, seven of 42 patients (16.7%) in the Erleada monotherapy group and 10 of 44 patients (22.7%) in the Erleada plus Zytiga and prednisone group. Lower rates of hot flashes and hypertension were reported in patients who received Erleada monotherapy.

Gynecomastia affected 23 of 42 patients (54.8%), and breast pain was reported by six of 42 patients (14.3%) in the Erleada monotherapy group, both higher than rates observed in the other two groups. No new safety signals were detected in
the study.

“Androgen Receptor Pathway Inhibitor Therapy for Advanced Prostate Cancer: Secondary Analysis of a Randomized Clinical Trial” by Dr. Diogo Assed Bastos et al., 

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In patients with advanced castration-sensitive prostate cancer, health-related quality of life (HRQOL) was similar across treatment groups receiving Erleada (apalutamide) alone, APA plus Zytiga (abiraterone acetate) and Deltasone (prednisone), or ADT plus AAP. The study, published in JAMA Network Open, found no significant differences in HRQOL scores at 25 weeks. However, the APA-alone group showed a more favorable time to deterioration in emotional well-being. PSA levels and overall survival rates were comparable, with varying side effect profiles across treatment groups.

A study found no significant HRQOL differences between Erleada-based therapies and ADT plus AAP for advanced castration-sensitive prostate cancer.

Tumor

Erleada Combo Shows Comparable Quality of Life Outcomes in Prostate Cancer

In a real-world setting, standard-of-care Carvykti (ciltacabta-gene autoleucel) has been shown to elicit responses from nearly all participating patients with relapsed/ refractory multiple myeloma (R/R MM).

Carvykti is a type of chimeric antigen receptor-T (CAR-T ) cell therapy, which, as explained by the National Cancer Institute, involves a patient’s T cells — part
of the immune system — being extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient.

Overall and complete response rates were 89% and 70%, respectively, in
all patients who received Carvykti, 94% and 74% in 191 patients who received conforming Carvykti and 95% and 76% in 152 patients treated with conforming Carvykti with fludarabine/ cyclophosphamide lymphodepletion.

A comforming treatment is administered according to the specifications of
the FDA’s approval, and lymphodepletion is a short course of chemotherapy administered before CAR-T cell therapy.

 for adults with R/R MM who had received at least four prior lines of treatment. In 2024, the agency approved Carvykti for patients who received at least one prior line of therapy.

, that led to the FDA’s 2022 approval of Carvykti, the overall response rate was 98%, with 83% stringent complete response, according to findings published in 2023.

Patients with R/R MM who underwent leukapheresis, or the collection of healthy white blood cells from a patient, for Carvykti manufacturing at 16 American academic medical centers were included in the study, published in Blood, with 255 patients undergoing leukapheresis and 236 receiving Carvykti.

Of the real-world patients, 54% would not have met the eligibility criteria for CARTITUDE-1.

Senior author Dr. Doris K. Hansen of Moffitt Cancer Center’s Department
of Blood and Marrow Transplant and Cellular Immunotherapy, explained in an interview with 

 why such real-world findings are significant.

“Clinical trials are invaluable because they serve as the gold standard for introducing new therapies and advancing science,” Hansen explained.

“However, clinical trials often have strict eligibility criteria. Patients must meet very specific criteria to participate — they need to have good organ function, stable blood counts and no significant comorbidities."

In contrast, Hansen said, the patients seen in day-to-day clinical practice often have a variety of health challenges, with many patients having comorbid conditions like cardiac issues or renal impairment, and with about 20% of those diagnosed with myeloma experiencing kidney problems. “Additionally,” Hansen said, “some patients may have plasma cell leukemia, amyloidosis or myeloma-related bone damage, which can lead to fractures, pain and even reduced mobility or wheelchair use. These factors often make patients ineligible for clinical trials. ... It is, therefore, very important to report on the experiences of these patients. By studying their outcomes, we can understand how treatments perform in real-world scenarios, as opposed to the controlled, ideal conditions of clinical trials.”

The eligibility criteria for CARTITUDE-1 included adequate organ function, limited comorbidities and having no prior exposure to B-cell maturation antigentargeted therapy.

Cytokine release syndrome was experienced by 75% of patients, with grade 3 (severe) or higher in 5%. Immune effector cell-associated neurotoxicity syndrome was seen in 14%, with grade 3 or higher in 4%. Delayed neurotoxicity was reported in 10% of patients.

Researchers reported a 10% nonrelapse mortality rate, mostly from infections, and noted that second primary malignancies, excluding nonmelanoma skin cancers, were seen in 5.5% of patients and myeloid malignancies/acute leukemia in 1.7%.

 such as Carvykti, as explained by the National Cancer Institute, involves a patient’s T cells, part of the immune system, being extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient. Carvykti is currently approved by the FDA to be administered in the second line of treatment.

Safety and Efficacy of Standard of Care Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma” by Dr. Surbhi Sidana, et al., 

Carvykti (ciltacabtagene autoleucel) demonstrates significant efficacy in real-world settings for relapsed or refractory multiple myeloma, with 89% of patients responding and 70% achieving complete response. Despite many patients not meeting clinical trial criteria, outcomes were comparable to the CARTITUDE-1 trial. At 13 months, median progression-free survival and overall survival were not reached, with 12-month estimates at 68% and 82%, respectively. Side effects included cytokine release syndrome and neurotoxicity. Carvykti, a CAR-T cell therapy, is FDA-approved for patients with multiple prior treatments.

The CAR-T cell therapy Carvykti has been shown to be effective among patients outside the confines of a clinical trial.

Carvykti Effective in Real-World Setting for Myeloma 

Among patients with stage 3 unresectable non-small cell lung cancer (NSCLC), the first participant has been dosed in the phase 2 CONVERGE study, according to a news release from biotechnology company Nanobiotix. The randomized, controlled clinical trial is evaluating the potential first-in-class radioenhancer JNJ-1900 (NBTXR3) in patients being treated with standard-of-care chemoradiation followed by consolidation Imfinzi (durvalumab).

“We believe the true value of [NBTXR3] is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment,” said Laurent Levy, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. “With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in [non-small cell lung cancer] NSCLC brings us another step closer to delivering for the large number of patients [NBTXR3] is designed to serve.”

Who is Eligible For CONVERGE Study Enrollment?

According to the clinical trial page
at clinicaltrials.gov, CONVERGE is evaluating the addition of NBTXR3 to concurrent platinum-based doublet chemotherapy with radiation therapy, followed by consolidation immunotherapy, and whether this enhances the objective response rate in patients with locally advanced, unresectable stage 3 NSCLC.

To be considered eligible for enrollment, patients must be candidates for chemotherapy with radiation therapy; have a pathologically confirmed NSCLC diagnosis within three months prior to enrollment; present with unresectable stage 3IIIA or 3IIIB NSCLC; have at least one target lesion suitable for intratumoral or /intranodal injection and external beam radiation therapy; and have an ECOG performance status of 0 or 1.

Participants are considered ineligible for enrollment in the study if they have a history of primary immunodeficiency; organ transplantation requiring immunosuppression; significant cardiac events within three months before enrollment; concurrent or recent malignancies other than NSCLC; and known hypersensitivity to study drugs or components.

Patients with active bleeding diathesis or patients requiring anticoagulation or antiplatelet therapy that cannot be safely modified for procedures are also excluded.

The novel, potentially first-in-class oncology product NBTXR3 comprises functionalized hafnium oxide crystal nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The proof-of-concept for NBTXR3 was demonstrated in soft tissue sarcomas, leading to the agent receiving a European CE mark in 2019.

The agent’s mechanism of action is designed to induce substantial tumor cell death within the injected tumor when activated by radiotherapy, thereby triggering an adaptive immune response and establishing long-term anticancer memory. Consequently, the company anticipates that NBTXR3 could be applied to any solid tumor treatable with radiotherapy and be adaptable to any therapeutic combination, especially with immune checkpoint inhibitors.

The radiotherapy-activated NBTXR3 is under evaluation for multiple solid tumor indications as a stand-alone treatment and in combination with anti-PD-1 immune checkpoint inhibitors. These initiatives include the global, randomized NANORAY-312 trial, which is focused on locally advanced head and neck squamous cell carcinomas. In February 2020, the Food and Drug Administration granted fast track designation to NBTXR3 activated by radiotherapy, with or without Erbitux (cetuximab), for patients with locally advanced head and neck squamous cell carcinoma who are ineligible for platinum-based chemotherapy.

In 2019, the company entered a comprehensive clinical research partnership with The University of Texas MD Anderson Cancer Center to sponsor multiple phase 1 and 2 trials evaluating NBTXR3 across various tumor types and therapeutic combinations. Nanobiotix announced a license agreement with Janssen Pharmaceuticals, a Johnson & Johnson company, for the global co-development and commercialization of NBTXR3 in 2023.

The phase 2 CONVERGE study has commenced dosing its first participant to evaluate the radioenhancer JNJ-1900 (NBTXR3) in stage III unresectable non-small cell lung cancer (NSCLC) patients. This trial investigates the efficacy of NBTXR3 combined with standard chemoradiation and consolidation durvalumab. NBTXR3, a hafnium oxide nanoparticle, is activated by radiotherapy to induce tumor cell death and an adaptive immune response. The study aims to enhance objective response rates in NSCLC, with eligibility criteria including specific NSCLC stages and performance status, while excluding certain medical conditions.

The first participant has been dosed on the phase 2 CONVERGE study evaluating NBTXR3 in stage III, unresectable non–small cell lung cancer.

Breaking Down the CONVERGE Study of NBTXR3 in Stage 3 Unresectable NSCLC

The woman who raised me and I did not always see eye to eye. In fact, as two stubborn, opinionated characters we frequently bickered, challenged and exchanged choice words with one another. 

As I reflect on 25 years strong with Mom, here are some of my favorite words that we exchanged. We gave each other many cards over the past few years, one of which she had told me she looked for a long time searching for the right message to express her feelings. It reads:

"When you have a daughter who makes you proud, makes you laugh and, very often, makes your day ... you know what joy is. When you have a daughter who is a good person with a gracious heart and generous spirit ... you know what peace is. When you have a daughter whose beauty (inside and out) is matched only by her compassion for others ... you know what love is. Because I have you for my daughter, I know what it is to be truly blessed."

When I first read those words — as I read them now — I feel so close to my mom. Recently, I found a card with the words that expressed how I feel about her. I read this aloud to her on Christmas Day.

"Dear Mom, I'm so grateful for the way I was raised. You were never afraid to be my mother — to put your foot down, to teach me right from wrong, to make sure I did my best. You always let me know I had a mama who cared about me, who believed in me, who was there for me no matter what. Growing up with that kind of love and support made such a difference in my life; it made me who I am today."

My mother was never afraid to voice her opinion or be one to mince words, to put it lightly; but she was always pure in her intentions and true in her actions, and I feel so clearly, so humbly loved. As I go forward, I remember her strength and purity, her fierce sense of pride, her generous heart and sensitivity, her sense of humor (she once packed me a peanut-butter-jelly-and-ham sandwich because I refused to pick one of the two). 

Throughout her life and especially in her fight against lung cancer, Mom set us an example in unconditional devotion, taught our family valuable life lessons and never lost her indomitable spirit.

I know Mom is with us now and always. Goodbyes are only for those who love with their eyes, because for those who love with heart and soul there is no such thing as separation. I love you Mom, Happy New Year. Rest in peace and God bless.

For more news on cancer updates, research and education, don’t forget to

The narrative reflects on a complex yet deeply loving relationship between a daughter and her mother, characterized by mutual respect and understanding despite frequent disagreements. The daughter cherishes the heartfelt words exchanged through cards, highlighting the mother's pride, love, and unwavering support. The mother, who battled lung cancer, exemplified strength, devotion, and humor, leaving a lasting impact on her family. The daughter expresses gratitude for her upbringing and acknowledges the enduring connection with her mother, emphasizing that true love transcends physical separation.

A Tribute to Mom

Among patients with stage 2/3 hormone receptor–positive, HER2-negative early breast cancer, Kisqali (ribociclib) plus nonsteroidal aromatase inhibitor (NSAI) showed consistent benefits in invasive disease-free survival (iDFS), distant disease-free survival (DDFS), recurrence-free survival (RFS) and distant relapse-free survival (DRFS), according to an analysis of the phase 3 NATALEE trial presented at the 

At a median follow-up of 44.2 months, results showed that the 4-year iDFS rates in premenopausal patients were 90.6% with the Kisqali-plus-NSAI regimen with letrozole or anastrozole (1115 patients) versus 85.3% with a NSAI alone (1123 patients). In postmenopausal patients, the 4-year iDFS rates were 86.8% with the Kisqali-plus-NSAI regimen versus 82.2% with NSAI alone, which was a Δ4.6% absolute improvement.

“This analysis showed that [Kisqali] in combination with letrozole or anastrozole lowered the chance of the cancer returned was safe to use in a broad population of patients with HR-positive, HER2-negative early breast cancer,” lead study author Dr. Kevin Kalinsky, professor and director in the Division of Medical Oncology of the Department of Hematology and Medical Oncology at Emory University School of Medicine, and the director of the Glenn Family Breast Center at Winship Cancer Institute, said in an oral presentation during the meeting. “[Kisqali] plus a NSAI provides treatment benefit to a broad range of patients with stage 2/stage 3 HR-positive, HER2-negative early breast cancer across menopausal status and age.”

Although survival outcomes in patients with hormone receptor–positive, HER2-negative early breast cancer have improved with the use of adjuvant endocrine therapy, there is still a risk of recurrence, influenced by menopausal status and age, Kalinsky explained.

To be eligible for NATALEE, patients must have had hormone receptor–positive/HER2-negative early breast cancer and prior endocrine therapy was permitted within 12 months prior to randomization. Patients had to have:

anatomical stage 2a disease, which could be N0 with grade 2 and evidence of high risk, a Ki-67 of at least 20%, Oncotype DX Breast Recurrence Score at least 26 or high risk via genomic risk profiling, or grade 3, or N1 disease;

or anatomical stage 3, which was N0, N1, N2 or N3.

Patients who were premenopausal were required to undergo ovarian suppression.

A total 5101 patients were randomized 1:1 to receive 400 milligrams of daily Kisqali on a three-weeks-on/1-week-off schedule for three years plus an NSAI regimen of letrozole or anastrozole for at least five years plus goserelin in men and premenopausal women, or the NSAI regimen alone.

The primary end point was iDFS using STEEP criteria; secondary end points were RFS, DDFS, overall survival, safety and tolerability, patient-reported outcomes and pharmacokinetics.

Stratification factors included anatomical stage (2 versus 3), menopausal status (men and premenopausal women versus postmenopausal women), receipt of prior neo(adjuvant) chemotherapy (yes versus no), and geographic location (North America/Western Europe/Oceania versus rest of world).

Prior NATALEE data showed a statistically significant benefit with iDFS with Kisqali plus NSAI versus NSAI alone in a larger population of patients with hormone receptor–positive/HER2-negative early breast cancer at risk of recurrence. Additionally, the absolute iDFS benefit had increased to 4.9% in a 4-year landmark analysis and was observed across subgroups.

In the analysis presented at the 2025 ASCO Annual Meeting, investigators reported on 4-year efficacy, safety and quality-of-life (QOL) outcomes with Kisqali plus NSAI specific to menopausal status and age from the NATALEE study.

Kalinsky noted that more premenopausal patients versus postmenopausal had an ECOG performance status of 0 (86.8% versus 80.1%, respectively), Ki-67 greater than 20% (39.9% versus 34.4%), stage 3 (62.2% versus 58.3%), N1 to N3 nodal stage (63.4% versus 56.9%) and T3/T4 tumors (28.7% versus 24.0%) at diagnosis.

The data cutoff date was April 29, 2024. Efficacy outcomes were further explored via menopausal status and then grouped by age. Overall, in premenopausal patients, the 4-year DDFS rates were 91.6% with Kisqali/NSAI and 86.6% with NSAI alone, 4-year RFS rates were 92% and 86.6%, respectively, and 4-year DRFS rates were 92.7% and 87.6%, respectively.

When examined in premenopausal patients younger than 40 years, the absolute benefit rate with Kisqali (237 patients) versus NSAI alone (276 patients) across iDFS, DDFS, RFS and DRFS end points were Δ6.3%, Δ7%, Δ5.5% and Δ6.5%, respectively.

These rates were slightly lower in premenopausal patients 40 years or older with Kisqali (878 patients) versus NSAI alone (847 patients): iDFS (Δ5%); DDFS (Δ4.4%), RFS (Δ5.3%) and DRFS (Δ4.7%).

The same analysis was conducted in postmenopausal patients. Overall, in this subgroup, the 4-year DDFS rates were 87.7% versus 83.6% with Kisqali or NSAI, respectively (Δ4.1%). The 4-year RFS rates were 88.8% versus 84.5% (Δ4.3%), and the 4-year DRFS rates were 89.2% versus 85.6% (Δ3.6%).

The outcomes were explored further in postmenopausal patients younger than 60 years. The absolute benefit rate with Kisqali (703 patients) versus NSAI alone (735 patients) across iDFS, DDFS, RFS and DRFS end points were Δ2.7%, Δ2.2%, Δ2.8% and Δ2.1%, respectively.

These absolute benefit rates were higher in postmenopausal patients 60 years or older with Kisqali (721 patients) versus NSAI alone (685 patients): iDFS (Δ6.4%); DDFS (Δ5.9%), RFS (Δ5.8%) and DRFS (Δ5%).

Kalinsky emphasized that the trial was not powered to detect differences with these exploratory analyses, adding that the data should be interpreted with caution.

Safety and dose modifications due to adverse effects (AEs) were examined by menopausal status. Kalinsky highlighted that in premenopausal patients overall (2178 patients), the Kisqali discontinuation rate due to AEs was 16.1%, and 75.4% discontinued without dose reductions; in patients younger than 40 years, these respective rates were 10.5% and 52%, and in patients 40 years and older, they were 17.5% and 79.2%, respectively.

The Kisqali dose reduction rate due to AEs was 22.4% in all premenopausal patients, followed by 27% and 21.1% in patients younger than 40 years and at least 40 years old, respectively.

“Premenopausal women were more likely to discontinue [Kisqali] without having had a dose reduction,” Kalinsky said.

In postmenopausal patients overall (2771 patients), the Kisqali discontinuation rate was 22.9% and 67.5% stopped treatment without experiencing dose reductions. These rates were 17.8% and 68% in patients younger than 60 years and 27.9% and 67.2% in patients 60 years and older. The Kisqali dose reduction rate due to AEs was 23.6% in all postmenopausal patients, followed by 24.2% and 22.9% in patients younger than 60 years and at least 60 years old, respectively.

Time to deterioration (TTD) in global health status (GHS) and physical functioning scales of the EORTC QLQ-C30 was similar between arms for all patient subgroups.

“Efficacy and safety of Kisqali plus nonsteroidal aromatase inhibitor in NATALEE: analysis across menopausal status and age” by Dr. Kevin Kalinsky, et al., 

“Kisqali plus endocrine therapy in early breast cancer” by Dr. Dennis Slamon, et al., 

“Adjuvant Kisqali plus nonsteroidal aromatase inhibitor in hormone receptor–positive/HER2-negative early breast cancer: 4-year outcomes from the NATALEE trial” by Dr. Peter Fasching, et al., 

Kisqali (ribociclib) combined with a nonsteroidal aromatase inhibitor (NSAI) demonstrated significant benefits in invasive disease-free survival (iDFS), distant disease-free survival (DDFS), recurrence-free survival (RFS), and distant relapse-free survival (DRFS) for patients with stage 2/3 hormone receptor-positive, HER2-negative early breast cancer. The phase 3 NATALEE trial showed improved outcomes across menopausal status and age groups, with notable efficacy in premenopausal patients. Safety profiles were consistent, with manageable adverse effects. The trial's exploratory analyses suggest caution in interpreting subgroup differences, emphasizing the need for further research.

Kisqali plus aromatase inhibitor improved outcomes across age and menopausal status in early hormone receptor–positive, HER2-negative breast cancer.

Dr. Breelyn Wilky

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