{"id":16320,"date":"2025-01-08T21:16:13","date_gmt":"2025-01-08T14:16:13","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=16320"},"modified":"2025-01-08T21:16:13","modified_gmt":"2025-01-08T14:16:13","slug":"published-in-annals-of-oncology-disitamab-vedotin-combined-with-pd-1-inhibitor-is-a-promising-treatment-for-locally-advanced-or-metastatic-urothelial-carcinoma","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=16320","title":{"rendered":"Published in Annals of Oncology: Disitamab Vedotin Combined with PD-1 Inhibitor is a Promising Treatment for Locally Advanced or Metastatic Urothelial Carcinoma"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

YANTAI, China<\/span><\/span>, Jan. 8, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0On Janurary 7th, 2025, Annals of Oncology<\/i> (IF: 56.7), a top oncology journal globally, published remarkable long-term follow-up results of a phase 1b<\/span>\/2 clinical trial on Disitamab Vedotin (DV)\u00a0(developed by Remegen Co., Ltd) combined with Toripalimab in treating locally advanced or metastatic urothelial carcinoma (la\/mUC) (NCT04264936, study ID: RC48-C014). This trial was supervised by Professor Jun Guo<\/span> and Professor Xi’nan Sheng’s teams from Peking University Cancer Hospital.<\/p>\n

\n

\"Annals<\/a>
Annals of Oncology<\/span><\/p>\n<\/div>\n

It is the first time that long-term follow-up data has been released for a HER2-targeted antibody-drug conjugate (ADC) and PD-1 inhibitor combination therapy in treating la\/mUC, marking it a significant milestone. The nearly-three-year follow-up data revealed an objective response rate (ORR) of 73.2% and median overall survival (OS) of 33.1 months, superior to data published from any other prospective clinical studies on ADC plus PD-1 combination therapies for la\/mUC.<\/p>\n

New Treatment Options for Patients with La\/mUC<\/b><\/p>\n

UC is the sixth most common cancer worldwide. GLOBOCAN 2022 estimated the year 2021 saw 614,298 new cases and 220,596 deaths of UC.\u00a0In recent years, the prognosis for patients with la\/mUC has significantly improved with new drugs and combination therapies approved, among which ADCs demonstrated outstanding potential.<\/p>\n

As a HER2-targeted ADC, DV has been approved in China<\/span> for patients with HER2-overexpressing (defined as immunohistochemistry [IHC] test results of 2+ or 3+) la\/mUC previously treated with platinum-containing chemotherapy. The approval is based on the pooled results of two studies (NCT03507166 and NCT03809013, study IDs: RC48-C005 and RC48-C009) where the ORR registered 50.5% and the median duration of response (DOR) registered 7.3 months.<\/p>\n

Multiple clinical studies on la\/mUCin recent years have confirmed the synergistic antitumor effects of ADC combined with immunotherapy. NCT04264936 offered stronger evidence as its long-term follow-up results published in the Annals of Oncology<\/i> demonstrated the high response rate, significant survival benefits, and manageable safety profile of the DV and Toripalimab combination therapy.<\/p>\n

DV Combined with Toripalimab: High Response Rate and Prolonged Survival<\/b><\/p>\n

NCT04264936 is an open-label, multicenter, investigator-initiated phase 1b<\/span>\/2 clinical trial investigating the safety and efficacy of DV in combination with Toripalimab for the treatment of patients with HER2-expressing la\/mUC. The dose-escalation study (phase 1b<\/span>) assessed two dose levels of DV (1.5 and 2.0 mg\/kg) combined with Toripalimab (3.0 mg\/kg) to determine the recommended phase 2 dose which was then evaluated in the dose-expansion stage (phase 2).<\/p>\n

From August 2020<\/span> to December 2021<\/span>, 41 patients were enrolled with a median age of 66 years. 53.7% of the participants were male, 70.7% had an ECOG performance status score of 1, 17 (41.5%) had lung metastasis, and 10 (24.4%) had liver metastasis.<\/p>\n

As of March 1, 2024<\/span>, among all participants, the ORR was 73.2% with 4 (9.8%) achieving complete response and 26 (63.4%) achieving partial response, the DCR was 90.2%, the median progression-free survival (PFS) was 9.3 months, the median DOR was 8.6 months, the median OS was 33.1 months and the 36-month OS rate was 49.2%.<\/p>\n

Subgroup analysis revealed ORR benefits across all subgroups regardless of the number of prior lines of systemic treatments, HER2 expression (IHC 1+\/2+\/3+), and PD-L1 expression status. The ORRs for chemotherapy-na\u00efve patients and those who progressed on platinum-based chemotherapy were 76.0% (19\/25) and 68.8% (11\/16), respectively. The ORRs for patients with HER2 IHC 3+, 2+, 1+, or 0 were 80.0%, 84.2%, 64.3%, and 33.3%, respectively. Compared with the three HER2 IHC 0 participants (one of whom achieved partial response), those with HER2 expression (IHC 1+\/2+\/3+) had a higher ORR (76.3% vs 33.3%) and longer PFS (median PFS: 9.3 vs 1.7 months).<\/p>\n

In summary, the DV and Toripalimab combination therapy has preliminarily demonstrated promising efficacy and manageable safety profile among patients with la\/mUC, wherein those with HER2 expression (IHC 1+\/2+\/3+) achieved high response rates and long-term survival benefits. These findings support the further exploration and validation of the benefits of DV combined with PD-1 inhibitors in treating la\/mUC.<\/p>\n

\n<\/div>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

YANTAI, China<\/span><\/span>, Jan. 8, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0On Janurary 7th, 2025, Annals of Oncology<\/i> (IF: 56.7), a top oncology journal globally, published remarkable long-term follow-up results of a phase 1b<\/span>\/2 clinical trial on Disitamab Vedotin (DV)\u00a0(developed by Remegen Co., Ltd) combined with Toripalimab in treating locally advanced or metastatic urothelial carcinoma (la\/mUC) (NCT04264936, study ID: RC48-C014). This trial was supervised by Professor Jun Guo<\/span> and Professor Xi’nan Sheng’s teams from Peking University Cancer Hospital.<\/p>\n

\n

\"Annals<\/a>
Annals of Oncology<\/span><\/p>\n<\/div>\n

It is the first time that long-term follow-up data has been released for a HER2-targeted antibody-drug conjugate (ADC) and PD-1 inhibitor combination therapy in treating la\/mUC, marking it a significant milestone. The nearly-three-year follow-up data revealed an objective response rate (ORR) of 73.2% and median overall survival (OS) of 33.1 months, superior to data published from any other prospective clinical studies on ADC plus PD-1 combination therapies for la\/mUC.<\/p>\n

New Treatment Options for Patients with La\/mUC<\/b><\/p>\n

UC is the sixth most common cancer worldwide. GLOBOCAN 2022 estimated the year 2021 saw 614,298 new cases and 220,596 deaths of UC.\u00a0In recent years, the prognosis for patients with la\/mUC has significantly improved with new drugs and combination therapies approved, among which ADCs demonstrated outstanding potential.<\/p>\n

As a HER2-targeted ADC, DV has been approved in China<\/span> for patients with HER2-overexpressing (defined as immunohistochemistry [IHC] test results of 2+ or 3+) la\/mUC previously treated with platinum-containing chemotherapy. The approval is based on the pooled results of two studies (NCT03507166 and NCT03809013, study IDs: RC48-C005 and RC48-C009) where the ORR registered 50.5% and the median duration of response (DOR) registered 7.3 months.<\/p>\n

Multiple clinical studies on la\/mUCin recent years have confirmed the synergistic antitumor effects of ADC combined with immunotherapy. NCT04264936 offered stronger evidence as its long-term follow-up results published in the Annals of Oncology<\/i> demonstrated the high response rate, significant survival benefits, and manageable safety profile of the DV and Toripalimab combination therapy.<\/p>\n

DV Combined with Toripalimab: High Response Rate and Prolonged Survival<\/b><\/p>\n

NCT04264936 is an open-label, multicenter, investigator-initiated phase 1b<\/span>\/2 clinical trial investigating the safety and efficacy of DV in combination with Toripalimab for the treatment of patients with HER2-expressing la\/mUC. The dose-escalation study (phase 1b<\/span>) assessed two dose levels of DV (1.5 and 2.0 mg\/kg) combined with Toripalimab (3.0 mg\/kg) to determine the recommended phase 2 dose which was then evaluated in the dose-expansion stage (phase 2).<\/p>\n

From August 2020<\/span> to December 2021<\/span>, 41 patients were enrolled with a median age of 66 years. 53.7% of the participants were male, 70.7% had an ECOG performance status score of 1, 17 (41.5%) had lung metastasis, and 10 (24.4%) had liver metastasis.<\/p>\n

As of March 1, 2024<\/span>, among all participants, the ORR was 73.2% with 4 (9.8%) achieving complete response and 26 (63.4%) achieving partial response, the DCR was 90.2%, the median progression-free survival (PFS) was 9.3 months, the median DOR was 8.6 months, the median OS was 33.1 months and the 36-month OS rate was 49.2%.<\/p>\n

Subgroup analysis revealed ORR benefits across all subgroups regardless of the number of prior lines of systemic treatments, HER2 expression (IHC 1+\/2+\/3+), and PD-L1 expression status. The ORRs for chemotherapy-na\u00efve patients and those who progressed on platinum-based chemotherapy were 76.0% (19\/25) and 68.8% (11\/16), respectively. The ORRs for patients with HER2 IHC 3+, 2+, 1+, or 0 were 80.0%, 84.2%, 64.3%, and 33.3%, respectively. Compared with the three HER2 IHC 0 participants (one of whom achieved partial response), those with HER2 expression (IHC 1+\/2+\/3+) had a higher ORR (76.3% vs 33.3%) and longer PFS (median PFS: 9.3 vs 1.7 months).<\/p>\n

In summary, the DV and Toripalimab combination therapy has preliminarily demonstrated promising efficacy and manageable safety profile among patients with la\/mUC, wherein those with HER2 expression (IHC 1+\/2+\/3+) achieved high response rates and long-term survival benefits. These findings support the further exploration and validation of the benefits of DV combined with PD-1 inhibitors in treating la\/mUC.<\/p>\n

\n<\/div>\n

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