Recent Breakthroughs in ADC Candidates at the ASCO Annual Meeting
The ASCO Annual Meeting showcased promising clinical data from Duality Bio, presenting new developments in ADC candidates. These advancements signal hope for patients battling advanced cancers. Duality Bio (HKEX: 9606.HK) brought to light findings from two significant trials involving their B7H3 ADC candidate, DB-1311/BNT324, and HER3 ADC candidate, DB-1310.
B7H3 ADC Candidate DB-1311/BNT324 Performance
In an exciting oral session, the data regarding the B7H3-targeted ADC candidate DB-1311/BNT324 was revealed. This ongoing Phase 1/2 trial focuses on patients with heavily pre-treated castration-resistant prostate cancer (CRPC). The preliminary results indicate a notable early clinical activity alongside a manageable safety profile, with minimal discontinuation rates.
Among the 52 patients who were evaluated for efficacy, the confirmed objective response rate (cORR) stood at 30.8%, with an impressive disease control rate (DCR) of 90.4%. Moreover, the study reported a 6-month rate of radiographic progression-free survival (rPFS) at 69.8% among 68 evaluable patients. Encouragingly, these outcomes were consistent across the various dosage levels (6 mg/kg and 9 mg/kg). Patients who underwent earlier treatment lines demonstrated better results, showing significant anti-tumor activity even in post-treatment lines.
The clinical trial is currently enrolling new patients, including those who are taxane-naïve and those who have undergone Lu-177 treatment, presenting an opportunity for further promising results.
Addressing the Unmet Need in Prostate Cancer
Given the rising incidence of prostate cancer, the need for effective therapies has never been more crucial. The DB-1311/BNT324 program has received Fast Track Designation from the U.S. Food and Drug Administration (FDA), signifying its potential in treating patients with advanced or metastatic CRPC that has not responded to standard treatments.
HER3 ADC Candidate DB-1310 Offers Encouraging Results
In addition, the presentation of DB-1310, a HER3 ADC candidate, demonstrated encouraging outcomes in patients with advanced solid tumors who have not found success with standard treatment protocols. Results from the first-in-human Phase I/IIa study highlighted a 31% unconfirmed objective response rate (uORR) among 123 patients, with a disease control rate (DCR) reaching 84%.
Notable results emerged from patients specifically diagnosed with EGFR-mutated non-small cell lung cancer (NSCLC), where the uORR reached 44% and DCR stood at 91%. The findings also showcased that patients received a median progression-free survival (mPFS) of 7 months, with a median overall survival (mOS) of 18.9 months, particularly impressive at a 5.5 mg/kg Q3W dose, where the uORR peaked at 66.7%.
DB-1310 has exhibited a well-tolerated safety profile, with the most frequent treatment-related adverse events being mild digestive and hematological issues, resulting in a low treatment-related discontinuation rate of just 3.5%. These promising results further endorse the development of DB-1310, both as a standalone treatment and in combination therapies with existing regimens such as EGFR TKIs and HER2-targeted therapies.
The Vision of Duality Bio
Duality Bio is dedicated to advancing ADC technology and therapies aimed at treating cancer and autoimmune conditions. With a strong commitment to innovation, the company has developed several ADC platforms protected by global intellectual property rights. Their robust pipeline is further supplemented by strategic collaborations with leading biotech innovators and global corporations.
Dedicating resources across 17 countries, Duality Bio has actively engaged in multiple clinical trials, enrolling more than 2,000 patients for a range of clinical-stage ADC candidates. As a global leader in ADC technology, the company remains focused on developing bispecific ADCs, novel payload structures, and specialized treatments for autoimmune diseases.
Frequently Asked Questions
What were the recent advancements presented by Duality Bio?
Duality Bio presented preliminary clinical trial results for their ADC candidates, demonstrating promise for patients with advanced cancers.
What is the B7H3 ADC candidate DB-1311/BNT324?
This candidate targets B7H3 and aims to treat heavily pre-treated castration-resistant prostate cancer with promising efficacy and safety results.
What results were highlighted for the HER3 ADC candidate DB-1310?
DB-1310 showed a 31% unconfirmed response rate in advanced solid tumors and great efficacy in patients with EGFR-mutated non-small cell lung cancer.
How is Duality Bio positioned in the ADC landscape?
Duality Bio is a leader in ADC technology development, with a strong pipeline and numerous strategic collaborations globally.
What does Fast Track Designation signify for DB-1311/BNT324?
This designation indicates a significant potential for this treatment to address unmet needs in prostate cancer therapies, expediting its development.
