Reported by Dr Annelies Verbiest, University Hospital Antwerp
Dr Annelies Verbiest, a medical oncologist at the University Hospital of Antwerp, has presented noteworthy findings from the mini-oral sessions on non-prostate genitourinary tumours.
Two trials investigated an intravesical drug delivery device for the continuous administration of drugs within the bladder, specifically in the context of BCG refractory NMIBC. The first trial assessed the safety and efficacy of the TAR-210 erdafitinib intravesical delivery system in NMIBC patients with select EGFR alterations. This study comprised two cohorts. Cohort 1 consisted of patients with high-risk NMIBC but no visible disease, with an 82% recurrence-free rate. Cohort 3 included intermediate-risk NMIBC patients with visible target lesions before treatment, with 87% achieving a complete response. The treatment duration was relatively short, approximately 3-6 months before data cutoff. Thus, the duration of response remains uncertain, but response rates appear promising. The SunRISe-1 study assessed TAR200, a drug delivery system for the sustained local release of gemcitabine in the bladder for patients with BCG refractory carcinoma in situ, a challenging tumour to treat. Here, 77% of patients achieved a complete response, with a median follow-up of about one year, and 91% maintained the response. In summary, it is too early to make definitive statements about clinical practice based on these trials and further experience is needed to evaluate potential toxicities, which appear to be primarily low-grade.
Additionally, three phase 1-2 studies were presented in the curative setting for MIBC. The ABACUS-2 phase II study investigated neoadjuvant atezolizumab in MIBC patients with non-urothelial histology. The study did not meet its primary endpoint of a 30% pathologic complete response. However, it is noteworthy that a subset of patients with sarcomatoid features had a 62% complete pathological response, highlighting the complexity of this aggressive tumour type. The NEMIO trial evaluated neoadjuvant ddMVAC (dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin) + durvalumab +/- tremelimumab for cisplatinum-eligible MIBC patients undergoing radical cystectomy. Pathological complete response rates were approximately 48% in both cohorts, which is consistent with the results of ddMVAC in the VESPER trial, suggesting no substantial practice-changing implications. Cohort L of the EV-103 study examined perioperative treatment with enfortumab vedotin monotherapy in cisplatin-ineligible MIBC patients, yielding a pathological complete response rate of 34%, slightly lower than other available combinations in this setting.
The TIDE-A study adopted a pragmatic approach to assess whether patients receiving the combination of axitinib plus avelumab, who achieved a tumour response, could be maintained on avelumab alone to reduce TKI-related toxicity and delay tumour resistance. Metastatic ccRCC patients with favourable prognostic features were considered. Patients with a durable response at 36 weeks of treatment were allowed to interrupt axitinib and resume it only upon disease progression. The study enrolled 89 patients, and 29 of them interrupted axitinib. At the first follow-up after eight weeks, 72.4% of these patients did not show disease progression. At the study’s cutoff, 11 patients remained on maintenance therapy. Among those who restarted axitinib upon disease progression, nearly one-third experienced further progression, emphasising the need for careful consideration when interrupting TKI therapy. Nevertheless, this study provides reassurance that TKI interruption can be done safely when necessary.
References:
Antoni Vilaseca – First safety and efficacy results of the TAR-210 erdafitinib (erda) intravesical delivery system in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations (alt). ESMO23 – LBA104
Andrea Necchi – Results From SunRISe-1 in Patients (Pts) With Bacillus Calmette–Guérin (BCG)-Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer (HR NMIBC) Receiving TAR-200 Monotherapy. ESMO23 – LBA105
Bernadett Szabados – A phase II study investigating the safety and efficacy of neoadjuvant atezolizumab in non-urothelial, muscle invasive bladder cancer (ABACUS-2). ESMO23 – 2363MO
Constance Thibault – Durvalumab (D) +/- tremelimumab (T) in combination with dose-dense MVAC (ddMVAC) as neoadjuvant treatment in patients with muscle-invasive bladder carcinoma (MIBC): results of NEMIO, a randomized phase I-II trial. ESMO23 -2364MO
Srikala Sridhar – Study EV-103 Cohort L: Perioperative treatment w/ enfortumab vedotin (EV) monotherapy in cisplatin (cis)-ineligible patients (pts) w/ muscle invasive bladder cancer (MIBC). ESMO23 – 2365MO
Roberto Iacovelli – Phase II study of avelumab (Ave) plus intermittent axitinib (Axi) in previously untreated patients (pts) with metastatic renal cell carcinoma (mRCC): The TIDE-A study. ESMO23 – 1884MO
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