Adjuvant nivolumab (Opdivo) monotherapy did not significantly improve disease-free survival (DFS) over placebo in patients with localized renal cell carcinoma (RCC) at high risk of post-nephrectomy relapse, failing to meet the primary end point of part B of the phase 3 CheckMate 914 trial (NCT03138512).

 showed that at a median follow-up of 27.0 months (95% CI, 18.0-42.4), the median DFS per blinded independent central review (BICR) was not reached in either the nivolumab arm or the placebo arm (HR, 0.87; 95% CI, 0.62-1.21; 

 = .3962). The 18-month DFS rates were 78.4% in the nivolumab arm and 75.4% in the placebo arm.

When evaluated via investigator, the median DFS was also not reached in either arm (HR, 0.80; 95% CI, 0.58-1.12; 

 = .1936), and the 18-month rates of DFS were 81.1% and 75.0%, respectively.

Because the primary endpoint of DFS per BICR was not met, no formal overall survival (OS) analysis will be performed, lead study author, Robert J. Motzer, MD, said in an oral presentation during the meeting.

However, patient subgroups that favored nivolumab vs placebo included patients with sarcomatoid features (HR, 0.42; 95% CI, 0.17-1.07), PD-L1 expression of 1% or greater (HR, 0.53; 95% CI, 0.22-1.29), and those with lower limit of normal hemoglobin at baseline (HR, 0.49; 95% CI, 0.25-1.49).

“Subgroup analysis from CheckMate 914 part A, which have been published previously, and presented previously, and part B suggest that there are tumor-specific characteristics that may influence outcomes for adjuvant nivolumab plus ipilimumab and nivolumab monotherapy treatment,” said Motzer, section head, Kidney Cancer, Genitourinary Oncology Service, and Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center.

Part A of the CheckMate 914 study was designed to evaluate the efficacy of adjuvant nivolumab plus ipilimumab (Yervoy) compared with placebo in patients with surgically resected stage II/III clear cell RCC with a high risk of relapse. At median follow up of 37.0 months (range, 15.4-58.0), part A did not meet the primary endpoint of DFS for the treatment combination, with a median DFS of NR with nivolumab/ipilimumab and 50.7 months with placebo (95% CI, 48.1-NE).

 The 18-month DFS rates were 78.8% and 76.6%, respectively.

Part B of the double-bind, randomized, phase 3 CheckMate 914 trial included 825 patients with radical or partial nephrectomy with negative surgical margins, predominant clear cell histology, no clinical or radiological evidence of residual disease or distant metastases after nephrectomy, and an ECOG performance status of 0 or 1.

 Pathologic TNM staging had to be pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; or pT any, G any, N1 M0.

Patients were randomized 2:1:1 to receive either 240 mg of intravenous (IV) nivolumab every 2 weeks for 12 doses plus placebo every 6 weeks for 4 doses (n = 411), IV placebo every 2 weeks for 12 doses plus placebo every 6 weeks for 4 doses (n = 208), or 240 mg of IV nivolumab every 2 weeks for 12 doses plus ipilimumab every 6 weeks for 4 doses (n = 206). Randomization occurred between 4 and 12 weeks after surgery.

Stratification factors included pathologic TNM staging and type of nephrectomy.

Secondary endpoints for this trial included DFS for nivolumab/ipilimumab vs nivolumab alone, OS for nivolumab vs placebo and nivolumab/ipilimumab vs nivolumab alone, and safety. An exploratory outcome was health-related quality of life. The data cutoff date was September 8, 2023.

The median ages of patients in the nivolumab monotherapy, placebo, and nivolumab/ipilimumab arms were 59 years (range, 25-86), 59 years (range, 25-80), and 60 years (range, 29-81), respectively. Ninety-three percent, 93%, and 94% of patients in each respective arm had a radical nephrectomy. In addition, most patients had pathological TNM staging of pT3, G any, N0 M0 at 82%, 81%, and 82%, respectively. Most patients also had a PD-L1 expression of less than 1% or not evaluable (85%, 89%, and 86%, respectively).

The median duration of therapy for all 3 arms was 5.1 months (range, <0.1-8.3). Overall, 327, 182, and 118 patients completed treatment in each respective arm. Discontinuations occurred in 20% of the nivolumab-alone arm, 12% of the placebo arm, and 42% of the combination arm; 11%, 1%, and 31% of patients discontinued due to study drug toxicity, respectively.

All-grade treatment-related adverse events (TRAEs) occurred in 73% of patients in the monotherapy arm, 52% of patients in the placebo arm, and 85% in the combination arm. Grade 3/4 TRAEs occurred in 9%, 2%, and 20% of patients in each respective arm. No patients died due to study drug toxicity.

The most common all-grade TRAEs in the nivolumab monotherapy, placebo, and combination arm, respectively, were pruritus (21% vs 15% vs 25%), fatigue (19% vs 16% vs 22%), hyperthyroidism (11% vs 1% vs 16%), hypothyroidism (11% vs 3% vs 21%), diarrhea (11% vs 9% vs 19%), rash (10% vs 6% vs 17%), asthenia (9% vs 8% vs 8%), arthralgia (8% vs 8% vs 11%), myalgia (5% vs 6% vs 9%), nausea (5% vs 5% vs 7%), headache (5% vs 3% vs 4%), alanine aminotransferase increase (5% vs 1% vs 10%), and maculopapular rash (5% vs <1% vs 7%).

Motzer noted that 6% of patients in the nivolumab monotherapy arm required corticosteroids to manage any-grade immune-mediated AEs vs 2% in the placebo arm and 19% in the nivolumab/ipilimumab arm.

The mean changes from FKSI-19 and EQ-5D-3L baseline scores were similar in both treatment arms and were not found to be meaningful.

Clinicians referring a patient to MSK can do so by visiting msk.org/refer, emailing referapatient@mskcc.org, or by calling 833-315-2722.

Bex A, Russo P, Tomita Y, et al. A phase III, randomized, placebo-controlled trial of nivolumab or nivolumab plus ipilimumab in patients with localized renal cell carcinoma at high-risk of relapse after radical or partial nephrectomy (CheckMate 914). 

. 2024;42(suppl; abstr LBA358). doi:10.1200/jco.2020.38.15_suppl.tps5099

 Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial. 

 2023;401(10379):821-832. doi:10.1016/S0140-6736(22)02574-0.

Articles

Adjuvant nivolumab monotherapy did not yield a disease-free survival benefit vs placebo in patients with localized renal cell carcinoma. 

Adjuvant Nivolumab Does Not Provide DFS Advantage in Localized, High-Risk RCC

Patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma experienced a clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) when treated with nivolumab (Opdivo) plus chemotherapy vs chemotherapy alone, according to data from the phase 3 CheckMate 649 study (NCT02872116) presented at the 

The 4-year follow up data revealed that the median OS in the overall population was 13.7 months (95% CI, 12.4-14.5) in the combination arm and 11.6 months (95% CI, 10.9-12.5) in the monotherapy arm (HR, 0.79; 95% CI, 0.71-0.88). In patients with a PD-L1 combined positive score (CPS) of 5 or greater, the median OS was 14.4 months (95% CI, 13.1-16.2) in the combination arm and 11.1 months (95% CI, 10.1-12.1) in the monotherapy arm (HR, 0.70; 95% CI, 0.61-0.81). In patients with a PD-L1 CPS of 1 or greater, the median OS was 13.8 months (95% CI, 12.4-14.8) in the combination arm and 11.4 months (95% CI, 10.7-12.3) in the monotherapy arm (HR, 0.75; 95% CI, 0.67-0.85).

The median PFS in the overall population was 7.7 months (95% CI, 7.1-8.6) in the combination arm and 6.9 months (95% CI, 6.7-7.2) in the monotherapy arm (HR, 0.80; 95% CI, 0.71-0.89). In patients with a PD-L1 CPS of 5 or greater, the median PFS was 8.3 months (95% CI, 7.0-9.3) in the combination arm and 6.1 months (95% CI, 5.6-6.9) in the monotherapy arm (HR, 0.71; 95% CI, 0.61-0.82). In patients with a PD-L1 CPS of 1 or greater, the median PFS was 7.5 months (95% CI, 7.0-8.4) in the combination arm and 6.9 months (95% CI, 6.2-7.1) in the monotherapy arm (HR, 0.77; 95% CI, 0.68-0.88).

“[Nivolumab] is the first PD-1 inhibitor plus chemotherapy combination to demonstrate long-term efficacy vs chemotherapy and acceptable safety after 4 years of follow-up in patients with previously untreated advanced [gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma],” Kohei Shitara, MD, medical oncologist and the chief of the Department of Gastrointestinal Oncology of the National Cancer Center Hospital East in Kashiwa, Japan, and lead study author, said during the presentation.

This randomized, open-label, global, phase 3 study included a total of 2031 patients, 789 of whom were in the nivolumab plus chemotherapy arm and 792 of whom were in the chemotherapy alone arm. Patients were randomized 1:1:1 to receive either nivolumab at 360 mg plus XELOX every 3 weeks or nivolumab at 240 mg plus FOLFOX every 2 weeks, XELOX every three weeks or FOLFOX every 2 weeks alone, or nivolumab at 1 mg/kg plus IPI at 3 mg/kg every 3 weeks for 4 doses, then 240 mg of nivolumab. The trial only focused on the first 2 arms.

The median age of patients enrolled in each arm was 62 and 61, respectively. Most of the population were male (68% vs 71%), had an ECOG performance status of 1 (58% vs 57%), had gastric cancer at initial diagnosis (70% vs 70%), had metastatic disease (96% vs 95%), and had microsatellite stability (88% vs 86%).

Patients with previously untreated, unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma with no known HER2-positive status and an ECOG performance status of 0 or 1 were eligible to enroll on trial. Patients were stratified based on tumor cell PD-L1 expression, region, ECOG performance status, and type of chemotherapy received.

Primary end points included OS and PFS in patients with PD-L1 CPS of 5 or more. Secondary end points were OS and PFS in all patients and in patients with PD-L1 CPS of 1 or greater and 10 or greater, as well as overall response rate (ORR). Other exploratory end points included safety and quality of life.

At the data cutoff, the minimum follow-up was 48.1 months. Three patients in the combination arm and 9 in the chemotherapy arm were still receiving treatment at cutoff.

ORR in the total population was 58% (54%-62%) in the combination arm and 46% (95% CI, 42%-50%) in the monotherapy arm, with most patients experiencing a partial response (47% vs 39%), as well as complete responses (11% vs 7%) and stable disease (28% vs 33%).

The median duration of response (DOR) in the overall population was 8.5 months (95% CI, 7.7-9.9) and 6.9 months (95% CI, 5.9-7.6) in each respective arm.

ORR in patients with PD-L1 CPS of 5 or greater was 60% (95% CI, 55%-65%) in the combination arm and 45% (95% CI, 40%-50%) in the monotherapy arm, with most patients experiencing a partial response (47% vs 38%), as well as complete responses (14% vs 8%) and stable disease (28% vs 34%). The DOR in this population was 9.6 months (95% CI, 8.3-12.4) and 7.0 months (95% CI, 5.7-8.0) in each respective arm.

No new safety signals were reported. Any grade treatment-related adverse effects (TRAEs) occurred in 95% of patients in the combination arm and 89% of patients in the monotherapy arm. TRAEs leading to discontinuation occurred in 42% and 26% of patients in each respective arm, with 19% and 10% in each arm resulting from grade 3/4 TRAEs.

The most common grade 3/4 TRAEs in the combination arm included neutropenia (16%), decreased neutrophil count (11%), anemia (6%), and increased lipase (6%). In the monotherapy arm, the most common grade 3/4 TRAEs included neutropenia (13%), decreased neutrophil count (9%), diarrhea (3%), peripheral neuropathy (3%), anemia (3%), and vomiting (3%). A total of 16 patients in the combination arm and 4 patients in the monotherapy arm experienced treatment-related deaths.

Shitara K, Moehler M, Ajani, J, et al. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4 year (yr) follow-up of CheckMate 649. Presented at the 2024 Gastrointestinal Cancers Symposium; San Francisco, CA, January 18-20, 2024. Poster 306.

Nivolumab plus chemotherapy improved PFS and OS vs chemotherapy alone in patients with advanced gastric, gastroesophageal junction, and esophageal cancers, according to 4-year data from the phase 3 CheckMate 649 study.

Nivolumab/Chemo Combination Sustains Survival Improvement in Gastric/GEJ Cancers

Brentuximab vedotin (Adcetris) plus nivolumab (Opdivo), doxorubicin, and dacarbazine was found to have efficacy and acceptable safety and tolerability when used as a frontline treatment in patients with previously untreated advanced, classical Hodgkin lymphoma, according to data from the phase 2 SGN35-027 trial (NCT03646123) presented at the 

A total of 93% of patients experienced a complete response (CR) or partial response (PR) at the end of treatment, with 88% having a CR (95% CI, 76.3%-94.9%). The PFS after 2 years was 88% (95% CI, 75.7%-94.6%), with 12% of patients experiencing PFS events, 11% experiencing disease progression, and 2% experiencing death.

"We still have 83% of the patients going on long-term follow up, and this [combination] represents very promising efficacy and tolerability and warrants further exploration in the setting of advanced stage classical Hodgkin lymphoma,” Hun Ju Lee, MD, an assistant professor of medicine in the Department of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center, said during the presentation.

Part B of this open-label, multi-part, multi-center phase 2 trial enrolled patients with stage III or IV Hodgkin lymphoma or stage II disease with bulky mediastinal disease of 10 cm or more. Patients were given 1.2 mg/kg of brentuximab vedotin intravenously, 240 mg of nivolumab, 25 mg/m2 of doxorubicin, and 375 mg/m2 of dacarbazine for up to 6 cycles.

Patients ranged in age from 19 to 78 years old; the median age was 35 years. Most patients had stage IV disease (51%), and 30% of patients had bulky stage II disease. A total of 58% of patients presented with B symptoms at time of initial diagnosis, and over 75% had intermediate- to high-risk disease with respect to International Prognostic Score (IPS). Almost all patients enrolled on trial received at least 1 dose (98%), and 83% of patients remain in long-term follow up. A total of 90% of patients completed treatment.

The primary endpoint for Part B of this study was the CR rate at end of treatment, and secondary endpoints included overall response rate (ORR), PFS, duration of response (DOR), and duration of complete remission (DOCR).

A total of 88% (95% CI, 75.7%-94.6%) of patients had a DOR of over 24 months, and 88% (95% CI, 76.0%-94.6%) had a DOCR of over 24 months.

The most common treatment-emergent adverse effects (TEAEs) of any grade were nausea (65%), fatigue (49%), peripheral sensory neuropathy (44%), alopecia (35%), diarrhea (32%), and constipation (26%). The most common grade 3 or higher TEAEs were an increase in alanine aminotransferase (11%), neutropenia (9%), an increase in aspartate aminotransferase (4%), fatigue (4%), and peripheral sensory neuropathy (4%). No grade 5 TEAEs were reported. Only 12% of patients discontinued treatment with brentuximab vedotin due to TEAEs, and 16% discontinued nivolumab due to TEAEs.

Immune-related TEAEs were experienced in 33% of patients, with the most common being hypothyroidism (9%), rash maculopapular (5%), pneumonitis (5%), an increase in aspartate aminotransferase (4%), an increase in alanine aminotransferase (4%), rash (4%), and dermatitis acneiform (4%). These TEAEs led to a discontinuation of nivolumab in 7% of patients.

Lee H, Flinn W, Melear J, et al. Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine for advanced stage classical Hodgkin lymphoma: efficacy and safety results from the single arm phase 2 study. Presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition; December 9-12; San Diego, CA; abstract 608.

Brentuximab vedotin plus nivolumab, doxorubicin, and dacarbazine was found to have efficacy and acceptable safety and tolerability when used as a frontline treatment in patients with previously untreated advanced, classical Hodgkin lymphoma.

Brentuximab Vedotin Combo Elicits Responses in Advanced Classical Hodgkin Lymphoma

The administration of axicabtagene ciloleucel (Yescarta; axi-cel) in the second-line setting improved overall survival (OS) and progression-free survival (PFS) vs standard-of-care treatment in patients with relapsed/refractory large B-cell lymphoma who are at least 65 years of age, according to data from a subgroup analysis of the phase 3 ZUMA-7 trial (NCT03391466) presented during the 

In the subgroup of patients aged 65 and older, the median OS in those receiving axi-cel vs standard of care was 43.5 months (95% CI; 20.9-not evaluable [NE]) and 19.5 months (95% CI; 12.3-NE), respectively (HR, 0.691; 95% CI, 0.401-1.190). In the subgroup of patients aged 70 years and older, the median OS in patients receiving axi-cel vs standard of care was 24.7 months (95% CI; 12.8-NE) and 11.2 months (95% CI; 6.1-NE), respectively (HR, 0.330; 95% CI, 0.135-0.809).

In the subgroup of patients aged 65 and older, the median PFS in patients receiving axi-cel vs standard of care was 28.6 months (95% CI; 5.1-NE) and 5.0 months (95% CI; 2.8-7.3), respectively (HR, 0.406; 95% CI, 0.230-0.715). In the subgroup of patients aged 70 years and older, the median OS in each arm was 11.4 months (95% CI; 4.1-NE;) and 2.7 months (95% CI; 1.7-5.0), respectively (HR, 0.206; 95% CI, 0.078-0.547).

“In the subgroup analysis, axi-cel as second-line therapy showed prolonged survival over standard of care in patients aged 65 years or older, including in patients aged 70 years or older,” said presenting author Marie José Kersten, MD, professor of hematology at Amsterdam University Medical Centers. “These findings confirm that age alone should not be a barrier for consideration of CAR T-cell therapy and support the use of axi-cel as a curative intense second-line therapeutic option for elderly patients with relapsed refractory large B-cell lymphoma.”

In the international phase 3 trial, patients with refractory large B-cell lymphoma or who had relapsed no more than 12 months after first-line chemoimmunotherapy were randomly assigned 1:1 to receive axi-cel or standard care, followed by high-dose chemotherapy with autologous stem-cell transplantation in patients with a response to the chemoimmunotherapy.2 Patients were able to receive cellular immunotherapy if they did not experience a response to standard of care. A total of 109 patients aged 65 and older were included in the subgroup analysis.

The primary endpoint of the study was event-free survival (EFS). Secondary endpoints included OS, PFS, and safety.

Improved OS in patients 65 years and older who received axi-cel was also associated with a greater proportion of naive T cells (HR, 0.369; 95% CI, 0.138-0.984).

Any-grade and grade 3 or higher adverse effects (AEs) of interest in the experimental arm vs control arm, respectively, were cytokine release syndrome (98% and 8% vs NE), neurological events (67% and 27% vs 25% and 2%), hypogammaglobulinemia (20% and 0% vs 2% and 0%), cytopenia (84% and 84% vs 82% and 76%), and infections (61% and 29% vs 38% and 16%). Death occurred in 51% of patients receiving axi-cel and 53% of patients receiving standard of care. Reasons for death included progressive disease (41% vs 36%), grade 5 AEs (4% vs 2%), new or secondary malignancies (2% vs 0%), and definitive therapy-related mortality (0% vs 2%).

Kersten M, N, Farooq U, Rapoport A, et al. Improved Overall Survival with Axicabtagene Ciloleucel vs. Standard of Care in Second-Line Large B-cell Lymphoma Among the Elderly: A Subgroup Analysis of ZUMA-7. Presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition; December 9-12; San Diego, CA; abstract 1761.

Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. 

. 2022;386(7):640-654. doi:10.1056/nejmoa2116133

The administration of axicabtagene ciloleucel in the second-line setting improved overall survival and progression-free survival vs standard-of-care treatment in patients with relapsed/refractory large B-cell lymphoma who are at least 65 years of age.

Second-Line Axi-Cel Prolongs Survival Over SOC in Elderly Patients With R/R LBCL

Treatment with fam-trastuzumab deruxtecan-nxki (Enhertu; T-DXd) generated clinical responses in patients with HER2-low or HER2-positive advanced breast cancer with pathologically confirmed leptomeningeal carcinomatosis, according to findings from cohort 5 of the phase 2 DEBBRAH trial (NCT04420598), which were shared at the 

Results of the 7-patient study showed that the median OS with trastuzumab deruxtecan was 13.3 months (95% CI, 5.7-not applicable; 

<.001). The 16-week OS rate was 86% (95% CI, 33%-98%), and the 24-week OS rate was 71% (95% CI, 26%-92%).

“Despite the limited sample size, T-DXd showed promising activity with no new safety concerns in HER2-positive and HER2-low patients with previously untreated, pathologically confirmed leptomeningeal carcinomatosis,” lead study author Marta Vaz Batista, MD, a medical oncologist of Hospital Professor Doutor Fernando Fonseca EPE in Lisbon, Portgual, and coinvestigators, wrote in the poster that was presented during the meeting.

In this single-arm, open-label, 5-cohort, phase 2 study conducted across 18 sites in Spain and Portugal, 39 patients over the age of 18 years received 5.4 mg/kg of T-DXd intravenously once every 21 days until disease progression, unacceptable toxicity, or consent withdrawal.

 Patients with pretreated HER2-positive or HER2-low advanced breast cancer with stable, progressing, or untreated brain metastases and/or leptomeningeal carcinomatosis were divided into 5 cohorts.

Cohort 5 consisted of 7 patients with HER2-positive or HER2-low advanced breast cancer and leptomeningeal carcinomatosis with positive cerebrospinal fluid cytology. The median age of the cohort was 57 years (range, 42-69). Six patients had less than 3 metastatic organ sites. Three patients had HER2-positive status vs 4 who were HER2 low. The median time before the last prior therapy was 1.9 months (range, 0.7-15). All 7 patients in the cohort had received systematic treatment through chemotherapy, 3 through anti–HER2 therapy, and 3 through endocrine therapy.

Secondary end points included progression-free survival (PFS), overall response rate (ORR), clinical benefit rate, time to response, duration of response, and best percentage of change in tumor burden, as per RANO-BM (intracranial lesions) and RECIST v.1.1 (extracranial and overall lesions). Median PFS was 8.9 months (2.1-NR); the 16-week PFS rate was 86% (95% CI, 33%-98%), and the 24-week PFS rate was 71% (95% CI, 26%-92%).

At data cutoff if April 4, 2023, the median follow-up was 12 months (range, 2.5-18.6). The median duration of treatment was 9.0 months (range, 2.1-18.6). Two patients, 1 with HER2-positive and 1 with HER2-low disease, remained on treatment, after 18.6 months and 12.0 months, respectively.

Five patients had disease progression. No patients had intracranial progression, while 4 patients presented extracranial progression. One patient had clinical worsening. No objective responses were observed. Five patients had a prolonged stabilization of at least 24 weeks, resulting in an overall clinical benefit rate of 71.4% (95% CI, 29.0%-96.3%).

All 7 patients experienced any-grade treatment emergent adverse effects (TEAEs), and 3 experienced a grade 3 TEAE. The most common non–hematological TEAEs included nausea (any-grade, 57.1%; grade 3, 14.3%), fatigue (any-grade, 42.9%), vomiting (any-grade, 42.9%), headache (any-grade, 42.9%), and urinary tract infection (any-grade, 42.9%). 

In terms of hematological TEAEs, anemia (any-grade, 42.9%) and thrombocytopenia (any-grade, 28.6%; grade 3, 14.3%) were the most frequent. Four patients experienced serious unrelated TEAEs, and 1 patient experienced a treatment-related serious TEAE of grade 3 nausea. No treatment-related deaths were observed.

Further analysis with a larger patient population is required to understand the response of patients with leptomeningeal carcinomatosis to T-DXd treatment, the authors concluded.

Vaz Batista M, Pérez-García J, Garrigós L, et al. Trastuzumab deruxtecan in patients with HER2[+] or HER2-low advanced breast cancer and pathologically confirmed leptomeningeal carcinomatosis: results from cohort 5 of the DEBBRAH study. Presented at the 2023 San Antonio Breast Cancer Symposium; December 5-9, 2023; San Antonio, TX. Abstract PS11-05.

Pérez-García JM, Vaz Batista M, Cortez P, et al. Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: the DEBBRAH trial. 

. 2023;25(1):157-166. doi:10.1093/neuonc/noac144

Treatment with trastuzumab deruxtecan generated clinical responses in patients with HER2-low or HER2-positive advanced breast cancer with pathologically confirmed leptomeningeal carcinomatosis. 

Rina Lokaj

Articles

Adjuvant Nivolumab Does Not Provide DFS Advantage in Localized, High-Risk RCC

Nivolumab/Chemo Combination Sustains Survival Improvement in Gastric/GEJ Cancers

Brentuximab Vedotin Combo Elicits Responses in Advanced Classical Hodgkin Lymphoma

Second-Line Axi-Cel Prolongs Survival Over SOC in Elderly Patients With R/R LBCL

T-DXd Yields Early Activity in HER2+/HER2-Low Breast Cancer With Leptomeningeal Carcinomatosis