Aidixi (disitamab vedotin)

Neoadjuvant cisplatin-based combination chemotherapy or perioperative durvalumab with neoadjuvant gemcitabine-cisplatin has been the primary treatment for localized muscle-invasive bladder cancer (MIBC)...Twenty-five patients (cT2-4aN0-2M0) received at least four cycles of RC48 (2.0 mg/kg, Q2W or Q3W) with toripalimab, tislelizumab, or pembrolizumab, followed by radical cystectomy...Treatment-related adverse events were manageable. These findings suggest that RC48 combined with PD-1 inhibitors is a promising neoadjuvant strategy for localized MIBC and warrants further validation in biomarker-selected populations.

Thus, this combination therapy may offer a promising, effective, and well-tolerated treatment alternative for similar patients. Further clinical trials are warranted to validate these findings and potentially establish a new standard of care for this subset of lung cancer patients.

Postoperatively, a surgery combined with targeted and immunotherapy regimen was initiated: leuprorelin + rezvilutamide for the acinar adenocarcinoma and disitamab vedotin + toripalimab for the urothelial carcinoma. The protocol of surgery combined with targeted and immunotherapy offers a new treatment strategy for this rare malignancy. This study provides valuable insights for clinical diagnosis and management.

There are barriers to the clinical use of cisplatin-based neoadjuvant regimens in muscle-invasive bladder cancer (MIBC), especially for patients with renal dysfunction, hearing loss, heart diseases, or other severe comorbidities. Treatment-related adverse events primarily included aspartate aminotransferase elevation (35%), alanine aminotransferase elevation (38%), a decrease in appetite (23%), alopecia (23%), and sensory neuropathy (23%). Validation of the long-term efficacy of this regimen is required.

P2, N=144, Not yet recruiting, Cancer Hospital Affiliated to Shandong First Medical University; Cancer Hospital Affiliated to Shandong First Medical University

A total of 645 patients from 5 trials investigating anti-nectin-4 (enfortumab vedotin, EV), anti-TROP2 (sacituzumab govitecan, SG), and anti-HER2 (disitamab vedotin, DV) ADCs were identified. Hepatotoxicity was predominantly found in anti-HER2 regimens. While ADC-based combination regimens show promising responses, they also have high rates of AEs in patients with aUC.

Disitamab vedotin-toripalimab led to a significantly greater improvement in outcomes than chemotherapy among patients with untreated HER2-expressing locally advanced or metastatic urothelial cancer. (Funded by RemeGen and others; RC48-C016 ClinicalTrials.gov number, NCT05302284; ChinaDrugTrials.org.cn number, CTR20220348.).

The combination of endoscopic TLA with perioperative systemic therapy demonstrated promising efficacy and manageable safety in selected patients with localized high-risk UTUC. Our results suggest that there is potential for a paradigm shift in the management of this challenging patient population.

RC48 plus PD-1 inhibitor for pre-treated advanced G/GEJC patients with HER2 2+/3+ demonstrated superior efficacy than RC48 monotherapy and favourable safety. This combination represents a potential therapeutic strategy, but further large-scale prospective studies are still needed.

HER2 was frequently expressed in both primary tumors and metastatic LNs in EMPD patients, though heterogeneity was observed. HER2 status should be assessed in both primary and metastatic sites. Disitamab vedotin shows promise for treating HER2-positive advanced EMPD, warranting further study.

P3, N=182, Not yet recruiting, Fudan University