Enhertu Demonstrates Potential for First-Line Therapy Expansion
Q901 Gains Attention as a Key Player in ADC Combination Strategies
Securing Differentiation as the Only Drug Proven to Have Synergistic Effects with ADCs
Enhertu, an antibody-drug conjugate (ADC) cancer therapy jointly developed by the British pharmaceutical company AstraZeneca and the Japanese pharmaceutical company Daiichi Sankyo, has recently demonstrated its potential as a first-line treatment in clinical trials involving patients with HER2 (human epidermal growth factor receptor 2)-positive breast cancer.
ADCs based on topoisomerase I (TOP1) inhibitors are rapidly expanding their market presence, moving beyond existing subsequent-line therapies to earlier lines of treatment. Enhertu has not only achieved positive results in recent global Phase 3 clinical trials, but has also shown continued success in neoadjuvant therapy for early-stage breast cancer, once again demonstrating the potential to change the paradigm of cancer treatment.
There is a growing trend of prescribing ADC-based therapies from the early stages of cancer treatment. As more patients receive these therapies, the importance of strategies for subsequent treatments is also increasing. The issue of resistance to TOP1 inhibitor-based payloads has emerged as a significant challenge. While most ADCs utilize TOP1 inhibitors that cause intracellular DNA damage, persistent concerns have been raised about treatment resistance due to the activation of DNA damage repair mechanisms in cancer cells.
According to the new drug development industry and Qurient on May 15, overcoming these limitations has become a major trend in the global biotech sector. This is why Q901, a CDK7 inhibitor under development by Qurient, is attracting attention. Q901 fundamentally blocks the DNA damage repair capability of cancer cells by regulating the cell cycle and inhibiting transcription, and is therefore considered a strategic combination drug that can induce a strong anticancer synergistic effect when used in combination with TOP1 inhibitor-based ADCs.
According to preclinical research presented by Qurient at the American Association for Cancer Research (AACR) last year, Q901 demonstrated a significant tumor suppression effect in HER2-negative models when combined with Enhertu, compared to monotherapy. In the ongoing Phase 1 clinical trial, which is nearing completion, Q901 has proven its safety even at doses up to seven times higher than those showing anticancer activity. It is being evaluated as a drug with an optimal profile as a combination partner. To date, Q901 is the only CDK7 inhibitor that has been scientifically proven to have a combinatorial effect with ADCs, securing a unique differentiating point in the global oncology market.
Nam Kiyeon, CEO of Qurient, said, "The recent clinical results of Enhertu demonstrate that TOP1 inhibitor-based ADCs are a powerful platform capable of advancing to first-line therapies," adding, "Q901 is a key combination candidate that can further expand the success of this platform, and we are actively considering collaboration opportunities with multiple global pharmaceutical companies."
Qurient is currently conducting the global Phase 1 clinical trial of Q901 in the United States. In addition to combination development strategies with various ADCs, including Enhertu, the company is also discussing with partners the possibility of developing dual-payload ADCs that combine Q901 with TOP1 inhibitors.
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