In cisplatin-eligible patients with muscle-invasive bladder cancer, perioperative durvalumab plus neoadjuvant chemotherapy led to significant improvements in event-free survival (estimated event-free survival at 24 months was 67.8% versus 59.8%; HR: 0.68; [95% CI, 0.56 to 0.82]; P<0.001) and overall survival as compared with neoadjuvant chemotherapy alone (estimated overall survival at 24 months was 82.2% versus 75.2% ; HR: 0.75; [95% CI, 0.59 to 0.93]; P=0.01). Treatment-related adverse events of grade 3 or 4 in severity were similar between both groups (40.6% and 40.9 in the durvalumab and the comparison group, respectively.
- In patients with previously untreated stage II or III triple-negative breast cancer, neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab resulted in a significant improvement in overall survival, as compared with neoadjuvant chemotherapy alone (estimated overall survival at 60 months 86.6% versus 81.7 % (P=0.002)).
- In early stage triple negative breast cancer patients, neoadjuvant nivolumab, with or without ipilimumab, but without chemotherapy, demonstrates potential efficacy and warrants further investigation. Of 15 patients with high levels of TILs who received 6 weeks of neoadjuvant nivolumab and ipilimumab followed by surgery, 53% (8 patients) had a major pathological response (<10% viable tumor) at resection, with 33% (5 patients) having a pathological complete response. Grade 3-5 adverse events were observed in 17% of patients.
- In 30 patients with locally advanced unresectable or metastatic TNBC, adding ivonescimab (targeting both PD-1 and VEGF) to paclitaxel or nab-paclitaxel, showed an ORR and DCR of 72.4% and 100%, respectively. A total of 46.7% of patients experienced at least one Grade ≥3 treatment-related adverse event, but none led to treatment discontinuation or deaths.
- In a similar study, 42 patients with locally advanced or metastatic TNBC were treated with another bispecific antibody targeting PD-L1 and VEGF ( PM8002/BNT327) on top of nab-paclitaxel in patients. After a median follow-up of 16.3 months, median PFS was 13.5 months, whereas the confirmed ORR and DCR was 73.8% and 95.2%, respectively. A total of 57.1% of patients had grade ≥3 events.
- In patients with early-stage, high risk, ER+, HER2- breast cancer, the addition of durvalumab (whether or not with oleclumab, an adenosine-targeting agent) to neoadjuvant chemotherapy and stereotactic body radiation therapy, suggested a beneficial effect on the residual cancer burden (RCB 0/1 51.1% versus 37.8%) and pathological complete response ((35.6 % versus 17.8%) at surgery.
In patients with locally advanced cervical cancer, pembrolizumab plus chemoradiotherapy significantly improved 36-month overall survival versus chemoradiotherapy alone (36-mo OS 82.6% vs. 74.8%; HR: 0.67 [95% CI 0.50–0.90]; p=0·004) at a median follow-up of 29.9 mo. Grade 3 or higher adverse events were observed in 78% and 70% in the pembrolizumab-chemoradiotherapy group and placebo-chemoradiotherapy group, respectively.
