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On July 14, the official website of CDE revealed that Rongchang Biotech's ADC product Vidicuzumab for a new indication for marketing was accepted by CDE
.
According to public information, the fastest-growing indication is urothelial cancer, which is speculated to be the indication for this application
The clinical trial of vedicitumumab registered in China
From the Insight database
At present, the phase II clinical trial (CTR20180438) of vedicitumumab for HER2 overexpression (IHC 2+ or IHC 3+) urothelial carcinoma patients has been completed
.
Based on the positive clinical results of this phase II clinical trial and communication with NMPA, Rongchang subsequently launched a multi-center, single-arm, open-label phase II registered clinical trial (CTR20182469) to evaluate the use of disitamab vedotin as a monotherapy Efficacy of China in the treatment of HER2 overexpression UC
At the 2021 ASCO conference, Rongchang Biotechnology released the single-arm, multi-center phase II clinical study data of Vidicuzumab for HER2 overexpression locally advanced or metastatic urothelial carcinoma (abstract number: #4584)
.
From December 2018 to September 2020, a total of 64 patients were enrolled, of which 85.
9% had received second-line and above treatment in the past
At the same time, Rongchang also cooperated with Junshi to carry out a phase Ib/II clinical trial of vedicitumumab combined with teriprizumab for locally advanced or metastatic urothelial cancer
.
As of April 28, 2021, a total of 19 patients had completed at least one treatment administration, and 17 patients had completed at least one efficacy evaluation
In terms of breast cancer, Rongchang has initiated the phase III clinical trial of vedicitumumab for patients with low HER2 expression (click here to view the clinical trial details)
.
This clinical study aims to compare the effectiveness, safety and quality of life of vedicitumumab and paclitaxel/docetaxel/vinorelbine/capecitabine in the treatment of locally advanced or metastatic breast cancer with low HER2 expression , The primary end point is PFS, and the domestic target is to enroll 366 people
This year’s ASCO Shang Rongchang also disclosed a pooled analysis of two clinical data on the use of vedicitumumab in breast cancer, respectively, for HER2 positive (IHC 3+, or IHC 2+/FISH+) and HER2 low expression (IHC 2 +/FISH-, or IHC 1+)
.
As of December 31, 2020, 118 female breast cancer patients were included in the study
In the HER2-positive subgroup, the confirmed ORR of patients in the 1.
5, 2.
0, and 2.
5 mg/kg dose groups were 22.
2% (95% CI: 6.
4%, 47.
6%) and 42.
9% (95% CI: 21.
8%, 66.
0%), respectively ) And 40.
0% (95%CI: 21.
1%, 61.
3%).
The median PFS in the 1.
5, 2.
0, and 2.
5 mg/kg dose groups were 4.
0 months (95% CI: 2.
6, 7.
6) and 5.
7 months (95% CI: 2.
6, 7.
6), respectively.
% CI: 5.
3, 8.
4) and 6.
3 months (95% CI: 4.
3, 8.
8); in the HER2 low expression subgroup, the confirmed ORR and median PFS were 39.
6% (95% CI: 25.
8%, 54.
7%) And 5.
7 months (95%CI: 4.
1, 8.
3)
.
The results of this study showed that RC48 showed consistent efficacy in HER2-positive and HER2-low-expressing advanced breast cancer, and no new safety risks were found
.
Compared with other dose groups, 2.
In addition, in terms of NSCLC, an open-label phase Ib clinical trial is underway to evaluate the efficacy of vedicitumumab as a single agent in the treatment of HER2 overexpression NSCLC; in terms of BTC, a single-arm, open-label phase II clinical trial is underway.
To evaluate the efficacy of vedicitumumab as a single agent for HER2 overexpression BTC patients after the failure of first-line chemotherapy
.
The HER2 target is now highly competitive, and the Insight database shows that 50% of the current domestic ADC projects are concentrated on the HER2 target
.
In addition to the 2 already approved, 17 projects are still in clinical development
.
As the first domestically approved HER2 ADC, Rongchang Biotechnology undoubtedly takes the lead and is expected to seize more shares through market expansion and multi-indication development
.
HER2 ADC domestic competition (Insight)
From the Insight database
