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Bavencio plus best supportive care improves survival outcomes in advanced urothelial carcinoma, regardless of diabetes status.

Among patients with advanced urothelial carcinoma, first-line maintenance treatment with Bavencio (avelumab) plus best supportive care (BSC) prolonged overall survival (OS) and progression-free survival (PFS) versus BSC, regardless of diabetes mellitus status, according to exploratory analyses from the phase 3 JAVELIN Bladder 100 trial.

, which showed that in the subgroup of patients with diabetes mellitus, those who received Bavencio plus BSC (55 patients) achieved a median OS of 20.8 months versus 14.5 months with BSC alone. At two years, OS rates were 44.5% and 34.1%, respectively. At three years, OS rates were 33.1% and 20.3%, respectively. Among patients without diabetes, median OS was 24.7 months with Bavencio plus BSC versus 15.8 months with BSC alone. The two-year OS rates were 50.7% and 39.4%, respectively. The three-year OS rates were 36.6% and 31.9%.

Similarly, PFS was prolonged in both patient subgroups. In those with diabetes, median PFS was 5.6 months with Bavencio plus BSC versus 2 months with BSC alone. At two years, PFS rates were 18.5% and 9.2%, respectively. At three years, PFS rates were 13.5% and 5.5%, respectively. In patients without diabetes, median PFS was 5.4 months with Bavencio plus BSC versus 2.1 months with BSC alone. The 2-year PFS rates were 24.3% and 6.5%, respectively. The 3-year PFS rates were 16.3% and 5.3%, respectively.

Best supportive care (BSC): the optimal level of care provided to a patient.

Overall survival (OS): the average length of time that patients are alive after starting treatment or being diagnosed.

Progression-free survival (PFS): the amount of time a patient lives with a disease without it worsening.

Lipase: an enzyme that helps digest fats in food.

Amylase: an enzyme that breaks down carbohydrates, like starches, into simple sugars.

“Overall, these results show that Bavencio frontline maintenance is associated with long-term efficacy benefits and consistent safety in patients with advanced urothelial carcinoma with or without diabetes mellitus who are progression free after first-line platinum-based chemotherapy,” explained lead study author Dr. Shilpa Gupta, director of Genitourinary Medical Oncology at the Cleveland Clinic Taussig Cancer Institute in Ohio.

Background and Design of the JAVELIN Bladder 100 Trial

The trial included patients with unresectable locally advanced or metastatic urothelial carcinoma who remained progression free following 4 to 6 cycles of first-line platinum-based chemotherapy. Patients were assigned to receive frontline maintenance with Bavencio plus BSC or BSC alone. The exploratory analysis assessed long-term efficacy and safety outcomes in subgroups of patients with or without documented diabetes mellitus at randomization.

At a data cutoff of June 4, 2021, with at least two years of follow-up, median OS was significantly prolonged in the Bavencio plus BSC cohort compared with BSC alone, at 23.8 months versus 15.0 months, respectively.Similarly, median PFS was 5.5 months in the Bavencio arm versus 2.1 months in the BSC alone arm, demonstrating the clinical benefit of Bavencio maintenance therapy in this setting.

Results also demonstrated the long-term safety of Bavencio maintenance therapy, with health-related quality of life preserved throughout treatment. These results contributed to the inclusion of Bavencio frontline maintenance in updated international guidelines as a recommended treatment option for patients with advanced urothelial carcinoma.

Additionally, the study explored the effects of diabetes mellitus, a known risk factor for bladder cancer that is more prevalent in older adults. Previous research has suggested that diabetes may be associated with reduced efficacy of immunotherapy in some cancers; however, data in urothelial carcinoma remain limited. As a result, this post hoc exploratory analysis from JAVELIN Bladder 100 was conducted to assess outcomes in subgroups of patients with or without diabetes mellitus at randomization.

Baseline Patient Characteristics of JAVELIN Bladder 100 Post Hoc Analysis

Baseline demographics and disease characteristics were assessed by diabetes mellitus status, and median follow-up was at least 38 months in both treatment arms.

The median age among patients with diabetes mellitus was 70 years (range, 51-86) in the Bavencio plus BSC arm and 72 years (range, 57-89) in the BSC alone arm. Among patients without diabetes mellitus, the median age was 68 years (range, 37-90) with Bavencio and 69 years (range, 32-85) with BSC alone. Most patients were male in both diabetes subgroups (87.3% and 91.5% with Bavencio and BSC alone in the diabetes cohort, respectively, and 73.9% and 75.9% in the non-diabetes cohort).

Most patients were enrolled from Europe. Smaller proportions were from North America, Asia, and Australasia.

In the diabetes subgroup, 52.7% of patients in the Bavencio arm and 32.2% in the BSC arm were PD-L1 positive. Among patients without diabetes, 54.2% and 51.5% were PD-L1 positive in the Bavencio and BSC arms, respectively.

In the Bavencio plus BSC arm, grade 3 or greater treatment-related side effects (TRSEs) were reported in 24.1% (13 patients) of patients with diabetes and 18.6% (54 patients) of those without diabetes. The most common grade 3 of higher TRSEs were increased lipase, amylase and anemia. In the BSC alone arm, 1.7% of patients in both subgroups experienced any-grade TRSEs.

Serious side effects (SEs) occurred in 37.0% of patients with diabetes and 29.3% of those without diabetes receiving Bavencio. Among these, 9.3% and 10.3%, respectively, were classified as serious TRSEs. In the BSC alone group, 23.7% of patients with diabetes and 20.3% of those without diabetes experienced serious SEs, and no serious TRSEs were reported.

Bavencio discontinuation due to TRSEs occurred in 11.1% of patients with diabetes and 14.8% of those without diabetes, with 9.3% and 12.1% of cases directly attributed to TRSEs. TRSEs leading to death were rare, occurring in 1.9% of patients with diabetes and 2.1% of those without diabetes in the Bavencio group.

Immune-related SEs (irSEs) were observed in 31.5% (17 patients) of patients with diabetes and 32.4% (94 patients) of those without diabetes treated with Bavencio, compared with 3.4% and 1.4% of patients in the BSC alone group.

The most commonly reported TRSEs of any grade in the Bavencio plus BSC arm included pruritus (11.1% versus 15.5% in the diabetes and non-diabetes cohorts, respectively), hypothyroidism (7.4% versus 11.7%), fatigue (5.6% versus 11.7%), and asthenia (9.3% versus 10.7%). Gastrointestinal-related TRSEs, including diarrhea (7.4% versus 11.0%) and nausea (9.3% versus 6.9%), were also frequently observed.

“Avelumab first-line maintenance (1LM) in patients (pts) with advanced urothelial carcinoma (aUC) with or without diabetes mellitus (DM): long-term outcomes from JAVELIN Bladder 100,” By Dr. Shipla Gupta, et al. 

“Avelumab first-line maintenance for advanced urothelial carcinoma: results from the JAVELIN Bladder 100 trial after ≥2 years of follow-up,” by Dr. Thomas Powles, et al. 

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Articles

First-line maintenance treatment with avelumab (Bavencio) plus best supportive care (BSC) significantly improved overall survival (OS) and progression-free survival (PFS) in patients with advanced urothelial carcinoma, regardless of diabetes mellitus status. The JAVELIN Bladder 100 trial demonstrated prolonged OS and PFS in both diabetic and non-diabetic subgroups, with consistent safety profiles. The study's findings have led to the inclusion of avelumab in international guidelines as a recommended treatment option. The trial also explored the impact of diabetes, a known risk factor for bladder cancer, on treatment efficacy.

Patients with advanced urothelial carcinoma had prolonged survival with Bavencio and BSC treatment, regardless of diabetes mellitus status.

Bavencio and BSC Extends Survival in Bladder Cancer, Regardless of Diabetes Status

Maintenance Bavencio with Inlyta treatment interruption is feasible in patients with mRCC: © SciePro - stock.adobe.com.

Among patients with metastatic renal cell carcinoma (mRCC) who responded to frontline Bavencio (avelumab) and Inlyta (axitinib), updated phase 2 TIDE-A study findings presented at the 

 supported the feasibility of maintenance Bavencio with Inlyta treatment interruption.

Progression-free survival (PFS): time a patient lives without disease worsening.

Overall survival (OS): time from diagnosis or treatment start until death.

Objective response rate (ORR): percentage of patients with partial or complete response to treatment.

Partial responses (PR): reduction in tumor size, but not complete remission.

Disease control rate: percentage of patients with stable, partial, or complete response.

Hepatic metastases: cancer spread to the liver.

ECOG performance status of 0 or 1: scale of daily activity ability (0 = fully active, 1 = some limitations).

Bulky or symptomatic disease: large cancer-causing noticeable symptoms.

Findings showed that at a median follow-up of 31.7 months, patients in the overall population (75 patients) achieved a median progression-free survival (PFS) of 27.9 months. The median overall survival (OS) was not reached (NR), and the 24-month OS rate was 85%.

Among the patients who interrupted Inlyta at week 36 (29 patients), the median PFS and OS were both NR; the 24-month PFS and OS rates were 58% and 82%, respectively. The median duration of first Bavencio maintenance was 16 weeks.

“This analysis with a longer follow-up confirmed the feasibility of [Vascular endothelial growth factor, VEGF, tyrosine kinase inhibitors, TKI] interruption and the high response rate after VEGFR TKI reintroduction in patients receiving [Bavencio] maintenance,” lead study author Dr. Daniela Arduini, of Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, and colleagues wrote in a poster presentation of the data.

Following Inlyta interruption, five patients remained on Bavencio monotherapy without disease progression. One patient discontinued Bavencio due to side effects after 35.8 months of maintenance. Two patients continued Bavencio despite evidence of disease progression, and 21 patients restarted Inlyta.

Among patients who restarted Inlyta, the objective response rate (ORR) was 50%, with partial responses (PR) in 10 patients, stable disease in eight patients and progressive disease in two. The median PFS following Inlyta reintroduction was 17.2 months.

“The progression during maintenance with [Bavencio] alone did not affect the response to the subsequent TKI reintroduction. This strategy warrants further investigation in a randomized trial,” study authors added.

TIDE-A enrolled patients with metastatic RCC who had measurable disease, an ECOG performance status of 0 or 1, no bulky or symptomatic disease and no hepatic metastases.

Patients were excluded if they received prior systemic therapy for advanced RCC; received prior adjuvant or neoadjuvant treatment; had an active seizure disorder or evidence of active brain metastases, spinal cord compression, or carcinomatous meningitis; or had a history of another malignancy within two years prior to enrollment, with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ.

All enrolled patients initially received combination therapy with Bavencio at 800 milligrams (mg) once every two weeks plus Inlyta at 5 mg twice per day for 36 weeks. At week 36, patients underwent tumor evaluation, and those who achieved a PR — defined as a tumor volume reduction of at least 30% from baseline — discontinued Inlyta and continued Bavencio monotherapy at 800 mg once every two weeks until disease progression.

If disease progression occurred during Bavencio maintenance — defined as a tumor volume increase of at least 20% from the week 36 assessment — Inlyta was reintroduced at the same dose and discontinued again upon patients achieving a new PR. Patients who had stable disease at week 36 continued combination therapy until disease progression. Those with progressive disease at week 36 stopped all treatment.

The trial’s primary end goal was ORR at eight weeks following Inlyta discontinuation and initiation of Bavencio maintenance after 36 weeks of combination therapy. Secondary end goals included PFS, ORR for the combination period, disease control rate, OS, safety and patient-reported outcomes.

“Updated results of the TIDE-A study evaluating avelumab plus intermittent axitinib in previously untreated patients with metastatic renal cell carcinoma (mRCC),” by Dr. Arduini D, et al., 

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Updated findings from the TIDE-A study indicate the feasibility of maintenance Bavencio with Inlyta interruption in metastatic renal cell carcinoma (mRCC) patients. At a median follow-up of 31.7 months, the overall population achieved a median progression-free survival (PFS) of 27.9 months, with a 24-month overall survival (OS) rate of 85%. Among patients who interrupted Inlyta, the median PFS and OS were not reached, with 24-month rates of 58% and 82%, respectively. The study supports further investigation of this strategy in a randomized trial.

Updated TIDE-A study findings show that maintenance Bavencio with Inlyta treatment interruption is feasible in patients with metastatic renal cell carcinoma.

Bavencio Maintenance After Inlyta Interruption Shows Feasibility in mRCC

Padcev plus Keytruda maintained superior survival and progression-free benefits over chemotherapy in advanced urothelial cancer, reinforcing its SOC status.

Among patients with previously untreated locally advanced or metastatic urothelial carcinoma, frontline treatment with Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) continued to show superior efficacy over chemotherapy, including sustained progression-free survival (PFS) and overall survival (OS) benefits and durable responses, study results have shown.

Updated findings from the phase 3 EV-302/KEYNOTE-A39 trial presented during a rapid oral session at the 2025 ASCO Genitourinary Cancers Symposium indicated that at a median follow-up of 29.1 months, the doublet (442 patients) led to a median PFS of 12.5 months versus 6.3 months with chemotherapy (444 patients). The 12- and 24-month PFS rates with Padcev plus Keytruda were 51.4% and 37.1%, respectively; with chemotherapy, these rates were 21.7% and 12.6%.

The doublet also resulted in a median OS of 33.8 months versus 15.9 months with chemotherapy. The 12-month OS rates in the respective arms were 77.7% and 61.1%; at 24 months, these rates were 60.1% and 35.4%.

“After 2.5 years of median follow-up, we continue to show a compelling benefit for [Padcev] and [Keytruda] over chemotherapy,” Dr. Thomas B. Powles, said in a presentation of the data. “Median OS is 34 months, [which] I think is unprecedented compared with what we saw before. The frequency of treatment-related adverse effects [TRAEs] is consistent with what we saw previously…These data reinforce [Padcev] and [Keytruda] as the new standard of care in frontline urothelial cancer.”

Progression-free survival: the time a patient lives without their disease spreading or worsening.

Overall survival: the time a patient lives, regardless of disease status.

Objective response rate: patients who responded partially or completely to treatment.

Duration of response: how long a patient responds to treatment.

Complete response: the disappearance of cancer.

Powles is a professor of genitourinary oncology, lead for Solid Tumor Research, and director of Barts Cancer Centre at St. Bartholomew’s Hospital, Queen Mary University of London, in London.

Participants were randomized to receive Padcev at 1.25 mg/kg on days 1 and 8 and Keytruda at 200 mg on day 1 for 3 cycles versus chemotherapy in the form of cisplatin or carboplatin plus gemcitabine for a maximum of six cycles. Treatment continued until progressive disease by blinded independent central review (BICR), clinical progression, intolerable toxicity or the maximum cycles had been completed.

Data from the primary analysis showed that treatment with the doublet led to a median PFS of 12.5 months, compared with platinum-based chemotherapy, at 6.3 months. Moreover, the median OS with Padcev plus Keytruda was 31.5 months versus 16.1 months with chemotherapy.

These data supported the FDA’s decision to convert the accelerated approval of Padcev plus Keytruda in patients with locally advanced or metastatic urothelial cancer into a regular approval in December 2023. The regimen has also been approved on a global scale, including in Japan and Canada. “It resulted in transformative care across the world,” Powles noted.

The data cutoff date for the current analysis of the study was Aug. 8, 2024. With 29.1 months of median follow-up, 12% of patients on the doublet arm were still receiving treatment versus no patients on the chemotherapy arm. Moreover, 49% of those in the investigative arm versus 30% of those on the control arm remained on study.

Notably, the PFS benefit derived with Padcev plus Keytruda over chemotherapy proved to be consistent across prespecified subgroups, irrespective of primary disease site of origin, liver metastases, PD-L1 expression, platinum eligibility, presence of metastatic disease and renal function.

The same was true for OS benefit. “Again, the benefit is seen across these subgroups of patients; it doesn’t matter about platinum eligibility, liver metastases, PD-L1 expression, sites of metastatic disease, upper tract disease or performance status,” Powles noted.

Notably, the survival benefit achieved with the doublet was consistent with the overall population irrespective of cisplatin eligibility. In cisplatin-eligible patients, Padcev plus Keytruda (244 patients) led to a median OS of 36.7 months versus 18.7 months with chemotherapy (234 patients). In those not eligible for cisplatin, the median OS with the doublet (198 patients) and chemotherapy (210 patients) was 25.6 months and 12.7 months, respectively.

The confirmed objective response rate (ORR) in the investigative arm was 67.5% versus 44.2% with chemotherapy. The median duration of response (DOR) with the doublet was 23.3 months versus seven months with chemotherapy. The 12-month DOR rates with the doublet and chemotherapy were 67.5% and 35.1%, respectively; the 24-month rates were 49.4% and 24%.

“We were able to start looking at things like DOR because of the extended follow-up, and here, we show that among the responders, the probability of maintained response at two years was 50%,” Powles said. “Remember, it’s important to recognize that about 70% of these patients are responding, and they maintain their response at two years. In my opinion, I think that’s transformative. We also showed that 30% of patients had complete response [CR], which, again, was unprecedented in this setting.”

When taking a closer look at the duration of confirmed CR (cCR), they found that the probability of maintained CR at 24 months was 74.3% with Padcev plus Keytruda versus 43.2% with chemotherapy.

Powles concluded by noting that with an additional one year of follow-up, the toxicity profile of the doublet remained consistent with prior reports. No new safety signals were observed, and the frequency and grade of treatment-related side effects were consistent with what was shared in the primary analysis of the trial.

“EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC),” By Dr. Thomas B. Powles et al., Journal 

Frontline treatment with enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) demonstrates superior efficacy over chemotherapy in untreated locally advanced or metastatic urothelial carcinoma. The combination therapy shows significant improvements in progression-free survival (PFS) and overall survival (OS), with consistent benefits across various patient subgroups. The phase 3 EV-302/KEYNOTE-A39 trial results support the FDA's regular approval of the regimen, highlighting its transformative impact on global urothelial cancer care. The safety profile remains consistent, with no new adverse effects observed.

Padcev plus Keytruda was found to maintain benefit over chemotherapy in untreated locally advanced or metastatic urothelial cancer.

Padcev Plus Keytruda Results in Survival, Progression Benefits in Urothelial Carcinoma

Among patients with muscle-invasive bladder cancer (MIBC), treatment with adjuvant Opdivo (nivolumab) continued to showcase a benefit in disease-free survival (DFS) versus placebo, irrespective of previous treatment with neoadjuvant chemotherapy, according to data from an analysis of the phase 3 CheckMate-274 trial shared during the 

Adjuvant: any additional cancer treatment given after the primary treatment.

Disease-free survival: the time after treatment when someone is free of signs or symptoms of a disease.

Neoadjuvant: type of cancer treatment that is given before the main treatment.

Overall survival (OS): the average length of time that patients are alive after being diagnosed with or starting treatment for a disease.

In all randomized patients with MIBC, the median DFS was 25.6 months with Opdivo (353 patients) versus 8.5 months with placebo (356 patients). The 24-month DFS rates in the respective arms were 50.5% and 35.9%; at 36 months, these rates were 46.8% and 32%. The median follow-up in the intention-to-treat (ITT) population was 36.1 months; in the MIBC population, the median follow-up was 34.5 months.

In patients with MIBC who previously received neoadjuvant chemotherapy, the median DFS with Opdivo (279 patients) was 19.6 months versus 8.3 months with placebo (281 patients). In patients with MIBC who had not previously received neoadjuvant chemotherapy, the median DFS was 25.9 months with Opdivo versus 13.7 months with placebo.

Data from the interim overall survival (OS) analysis indicated that in all patients with MIBC, the median OS was not reached versus 39.9 months with placebo. The 24- and 36-month OS rates in the Opdivo arm were 75.3% and 64.2%, respectively; in the placebo arm, these rates were 66.2% and 53.7%, respectively.

In all randomized patients with MIBC and a tumor PD-L1 expression of at least 1%, the median OS with Opdivo was again not reached versus 37.6 months with placebo. Those with MIBC who received prior neoadjuvant chemotherapy adjuvant Opdivo experienced a median OS of 55.2 months versus 40.2 months with placebo. Those with MIBC without prior neoadjuvant chemotherapy experienced a median OS that was not reached with Opdivo versus 37.7 months with placebo.

“The improvements demonstrated in patients with MIBC provide additional support for adjuvant Opdivo as a standard of care for high-risk muscle-invasive urothelial carcinoma [MIUC,] including MIBC after radical surgery, and regardless of prior neoadjuvant chemotherapy,” Dr. Matthew I. Milowsky said in a presentation of the data. “Of note, subcutaneous Opdivo was approved for multiple indications, including as adjuvant therapy for MIUC by the FDA late last year, and might provide an alternative for patients across tumors.”

Milowsky is the George Gabriel and Frances Gable Villere Distinguished Professor of Bladder and Genitourinary Cancer Research, co-leader of the University of North Carolina (UNC) Lineberger Clinical Research Program, section chief of Genitourinary Oncology and co-director of the Urologic Oncology Program at UNC School of Medicine in Chapel Hill.

The randomized, double-blind, multicenter, phase 3 CheckMate-274 trial enrolled patients with ypT2 to ypT4a or ypN-positive MIUC who had neoadjuvant chemotherapy. Those with pT3a to pT4a or pN-positive MIUC without previously neoadjuvant chemotherapy who were not eligible for or refused adjuvant cisplatin chemotherapy were also included. Patients underwent radical surgery within the past 120 days and had to be free of disease within four weeks of undergoing randomization.

Participants were randomized to receive intravenous (IV) Opdivo or placebo at 240 mg every two weeks. They received adjuvant treatment for up to 1 year. Stratification factors included tumor PD-L1 status (at least 1% versus less than 1% or indeterminate), prior receipt of neoadjuvant chemotherapy (yes versus no) or nodal status.

The primary end points of the trial were DFS in all randomized patients and in the subset of patients with a tumor PD-L1 expression of at least 1%. Data showed that adjuvant Opdivo significantly improved DFS versus placebo in patients with high-risk MIUC post–radical surgery with or without cisplatin-based neoadjuvant chemotherapy. Extended follow-up data with a median of three years indicated that Opdivo continued to improve DFS versus placebo in all randomized patients, those with PD-L1 expression of at least 1% and those with MIBC. The first report of OS outcomes showed that survival favored Opdivo versus placebo in all randomized patients and the subset of patients with a PD-L1 expression of at least 1%.

For the post-hoc analysis shared at conference, the key end points were DFS in all randomized patients with MIBC and in those with MIBC according to previous neoadjuvant chemotherapy, and OS in all randomized patients with MIBC, those with MIBC and a tumor PD-L1 expression of 1% or higher and those with MIBC according to prior neoadjuvant chemotherapy.

Milowsky said that baseline clinical and demographic characteristics were generally well-balanced between the arms. “[They] were largely consistent between the ITT and MIBC populations. About 80% of patients in CheckMate-274 had bladder tumor origin. Of those patients with MIBC, about 50% received prior neoadjuvant chemotherapy and about 40% had tumor PD-L1 positivity,” he said.

Additional efficacy data indicated that in patients with MIBC who received prior neoadjuvant chemotherapy, the 24-month DFS rates with Opdivo and placebo were 48.9% versus 33.2%, respectively; the 36-month rates were 46.5% versus 28.9%, respectively. In patients with MIBC who had not received prior neoadjuvant chemotherapy, the 24-month DFS rates in the Opdivo and placebo arms were 52.1% versus 38.8%, respectively; the 36-month DFS rates were 46.9% versus 35.4%, respectively.

In all patients with MIBC and a tumor PD-L1 expression of at least 1%, the 24-month OS rate with Opdivo was 82.6% versus 67.4% with placebo; the respective 36-month rates were 71.8% and 52.0%. In those with MIBC and prior neoadjuvant chemotherapy, the 24-month OS rates with Opdivo and placebo were 73.6% versus 63.2%, respectively; the 36-month rates were 64.5% and 53.4%, respectively. In those with MIBC without prior neoadjuvant chemotherapy, the 24-month OS rate with Opdivo was 77.1% versus 69.4% with placebo; the respective OS rates at 36 months were 63.8% versus 53.9%.

“Safety in patients with MIBC was consistent with previous data in ITT patients, and no new safety signals were identified,” Milowsky concluded.

“Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: additional efficacy outcomes including overall survival in patients with muscle-invasive bladder cancer from CheckMate-274,” by Dr. Matthew I Milowsky, et al. 

“FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection.” FDA. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-and-hyaluronidase-nvhy-subcutaneous-injection

“Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma,” by Dr. Dean F. Bajorin. 

“Adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma: Expanded efficacy from CheckMate 274,” by Dr. Matthew D. Galsky. 

Adjuvant nivolumab (Opdivo) significantly improves disease-free survival (DFS) in patients with muscle-invasive bladder cancer (MIBC) compared to placebo, regardless of prior neoadjuvant chemotherapy, as demonstrated in the CheckMate-274 trial. The trial showed a median DFS of 25.6 months with Opdivo versus 8.5 months with placebo. Overall survival (OS) also favored Opdivo, with higher 24- and 36-month OS rates. The trial's findings support Opdivo as a standard adjuvant therapy for high-risk MIBC, with consistent safety profiles and no new safety signals identified.

Among patients with muscle-invasive bladder cancer, adjuvant Opdivo showed a continued benefit in survival versus placebo.

Jax DiEugenio

Bavencio and BSC Extends Survival in Bladder Cancer, Regardless of Diabetes Status

Bavencio Maintenance After Inlyta Interruption Shows Feasibility in mRCC

Padcev Plus Keytruda Results in Survival, Progression Benefits in Urothelial Carcinoma

Adjuvant Opdivo Continues to Provide Survival Benefit in Patients With High-Risk MIUC

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