A recent study found that treatment involving enfortumab vedotin and pembrolizumab produced significantly better outcomes than chemotherapy for patients with untreated locally advanced or metastatic urothelial carcinoma. The results of this study were published in the New England Journal of Medicine.

In this randomized, global, open-label phase 3 trial, a total of 886 patients were assigned in a 1:1 ratio to receive 3-week cycles of enfortumab vedotin (administered intravenously at a dose of 1.25 mg per kilogram of body weight on days 1 and 8) and pembrolizumab (administered intravenously at a dose of 200 mg on day 1) in the enfortumab vedotin-pembrolizumab group (N=442), or gemcitabine and either cisplatin or carboplatin in the chemotherapy group (N=444). Progression-free survival and overall survival were the primary endpoints of the study.

The enfortumab vedotin-pembrolizumab group exhibited a longer progression-free survival compared to the chemotherapy group, with a median of 12.5 months versus 6.3 months, respectively. Similarly, the overall survival was also prolonged in the enfortumab vedotin-pembrolizumab group, with a median of 31.5 months compared to 16.1 months in the chemotherapy group. In terms of treatment cycles, the enfortumab vedotin-pembrolizumab group had a median of 12 cycles (range, 1-46), while the chemotherapy group had a median of 6 cycles (range, 1-6). Notably, treatment-related adverse events of grade 3 or higher were observed in 55.9% of patients in the enfortumab vedotin-pembrolizumab group and in 69.5% of patients in the chemotherapy group.

Based on the above results, it can be concluded that treatment with enfortumab vedotin and pembrolizumab in patients with untreated locally advanced or metastatic urothelial carcinoma resulted in improved outcomes compared to chemotherapy.

According to a recent study, a propensity score analysis indicated an overall survival benefit for tebentafusp compared to nivolumab plus ipilimumab (N+I) in patients with untreated metastatic uveal melanoma (mUM). This study’s findings were published in the journal, Annals of oncology.

In this study, the overall survival (OS) of patients with untreated mUM were compared between those treated with tebentafusp or pembrolizumab (IMCgp100-202) and those treated with N+I (GEM1402) using propensity scoring methods. The analyses were adjusted using propensity score-based inverse probability of treatment weighting (IPTW), balancing age, baseline lactate dehydrogenase (LDH), sex, baseline alkaline phosphatase, Eastern Cooperative Oncology Group status, disease location, and time from primary diagnosis to metastasis. The OS was evaluated using Cox proportional hazard models and IPT-weighted Kaplan-Meier.

In the primary IPTW analysis, a total of 240 patients out of 252 who were assigned to receive tebentafusp from IMCgp100-202 were included, and 45 out of the 52 patients who underwent N+I treatment from GEM-1402 were also considered. After adjusting for IPTW, tebentafusp showed a favorable OS, with a hazard ratio (HR) of 0.52. The one-year OS for tebentafusp was 73%, while it was 50% for the N+I group. Sensitivity analyses consistently demonstrated a superior OS for tebentafusp, with all IPTW HRs ≤0.61.

Based on the above results, a propensity score analysis determined that tebentafusp provided  a similar  OS benefit compared to N+I in patients with untreated mUM. 

A recent study demonstrated that the utilization of sugemalimab alongside chemotherapy significantly improved progression-free survival and overall survival in treatment-naïve individuals with advanced esophageal squamous cell carcinoma (ESCC). This study’s findings were published in the journal, Nature medicine.

A total of 540 adults, ranging in age from 18 to 75 years, who were diagnosed with locally advanced, unresectable, recurrent or metastatic ESCC and had not undergone any previous systemic treatment, were enrolled in this multicenter, double-blinded, randomized, phase 3 trial. The patients were randomly assigned in a 2:1 ratio to receive either sugemalimab, an anti-PD-L1 antibody at a dose of 1,200 mg or placebo every 3 weeks for a maximum period of 24 months. Additionally, all the randomized patients underwent chemotherapy consisting of cisplatin (80 mg m^-2  on day 1) and 5-fluorouracil (800 mg m^-2 day^-1 on days 1-4) every 3 weeks for a maximum of six cycles. The study assessed both progression-free survival and overall survival outcomes.

With a median follow-up of 15.2 months, the extension of progression-free survival showed statistical significance when comparing sugemalimab plus chemotherapy to placebo plus chemotherapy (median 6.2 months vs 5.4 months). Additionally, overall survival was better with sugemalimab plus chemotherapy when compared to placebo plus chemotherapy (median 15.3 months vs 11.5 months). There was a notably higher objective response rate (60.1% vs 45.2%) observed with sugemalimab plus chemotherapy compared to placebo plus chemotherapy.

Thus, it can be concluded that the combination of sugemalimab and chemotherapy led to a notable extension in both progression-free survival and overall survival among treatment-naïve individuals with advanced ESCC.

A recent study showed that intensified AR blockade for a finite period extends prostate-specific antigen progression-free survival (PSA-PFS) while maintaining a manageable safety profile, without negatively impacting the time needed for testosterone recovery. This study’s findings were published in the Journal of clinical oncology.

The PRESTO trial was a randomized, open-label, phase III study that involved 503 patients diagnosed with biochemically recurrent prostate cancer (BRPC) and PSA doubling time of 9 months or less. Patients were randomly divided into one of three groups in a 1:1:1 ratio. These groups consisted of a 52-week treatment course with ADT (androgen-deprivation therapy) control, ADT combined with apalutamide, or ADT combined with apalutamide and AAP (abiraterone acetate plus prednisone). The primary endpoint of the trial was to evaluate PSA-PFS, which was defined as having a serum PSA level exceeding 0.2 ng/mL after the completion of the assigned treatment.

The median PSA level was determined to be 1.8 ng/mL (IQR, 1.0-3.6). During the initial planned interim analysis, it was observed that both experimental groups exhibited a significant prolongation in PSA-PFS when compared to the control group (median, ADT + apalutamide was 24.9 months vs 20.3 months for ADT alone; median, ADT + apalutamide + AAP was 26.0 months vs 20.0 months for ADT alone). There was no notable difference in the median time for testosterone recovery across the different treatment arms.

The above results demonstrated that the use of intensified AR blockade for a finite period has been found to PSA-PFS while maintaining a manageable safety profile and not interfering with testosterone recovery time. Consideration should be given to adding apalutamide to androgen deprivation therapy in high-risk BRPC patients.