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ADC Therapeutics presented updated clinical data on its Zynlonta and Cami


22/8/2021 | 2 minuty čtení

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Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic ADC to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept).


ADC Therapeutics presents updated clinical data of Zynlonta and Cami

ADC Therapeutics announced updated clinical data from the Zynlonta (loncastuximab tesirine-lpyl) Phase 2 LOTIS-2 trial in patients with relapsed or refractory DLBCL. In LOTIS-2, a single-arm, open-label, 145-patient Phase 2 clinical trial in patients with relapsed or refractory DLBCL who had failed 2 established therapies, Zynlonta demonstrated continued substantial antitumor activity and an acceptable safety profile.

Overall response rate was 48.3% and complete response rate was 24.8%. Median duration of response of 13.4 months for the 70 responders. Median duration of response not reached for patients with a complete response. Durable responses in high-risk patient groups, including: Patients with double- / triple-hit or transformed DLBCL each had a median DoR not reached. Patients with advanced stage disease (Stage III-IV) had a median DoR of 12.6 months. Median DoR for older patients was longer than for younger patients.

Patients with DLBCL refractory to first-line systemic therapy had a median DoR of 9.6 months compared with 12.6 months for patients who relapsed after responding to initial therapy. No new safety concerns were identified during the study.

Separately, the company announced updated interim results from the ongoing pivotal Phase 2 trial of camidanlumab tesirine (Cami) in patients with relapsed or refractory Hodgkin lymphoma presented at the 16th Annual International Conference on Malignant Lymphoma (ICML). The pivotal Phase 2 study is intended to support the submission of a BLA. Cami is being evaluated in a multicenter, open-label, single-arm Phase 2 clinical trial in 117 patients with relapsed or refractory Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT), including prior treatment with brentuximab vedotin and a checkpoint inhibitor.

The interim data cut includes 101 evaluable patients who had been in the study a median of 5.1 months. Patients were heavily pretreated with a median of 6 prior lines of systemic therapy. Key data include ORR of 66.3% (67/101 patients) with a complete response rate of 27.7% and partial response rate of 38.6%. No new safety signals have been identified.

Byondis eyes US filing for HER2-targeting ADC in advanced breast cancer

Byondis BV is gearing up for a US filing of an ADCs in advanced HER2-positive breast cancer, but CEO Marco Timmers has grand plans to partner up with big pharma and expand into other diseases. The Netherlands-based company has just announced top-line results from the Phase 3 TULIP study of [vic-]trastuzumab duocarmazine in HER2-positive unresectable locally advanced or metastatic cancer. That followed a fast-track development program where the company skipped midstage development and went straight for a larger trial.

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