Enhertu in HER2-Positive Metastatic Colorectal Cancer: DESTINY-CRC02 Trial
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
At the ASCO 2023 Annual Meeting, Dr. Kanwal Pratap Singh Raghav and colleagues from MD Anderson Cancer Center presented the results of the DESTINY-CRC02 Phase 2 clinical trial. This study investigated the efficacy and safety of Enhertu (Trastuzumab deruxtecan) in patients with HER2-positive advanced colorectal cancer (CRC).
Study Design: DESTINY-CRC02 Trial
The trial evaluated two different doses of Enhertu in patients with HER2-positive (IHC 3+ or IHC 2+/ISH positive) metastatic CRC who had progressed on prior therapies:
- 5.4 mg/kg Group (N=82)
- 6.4 mg/kg Group (N=40)
The primary endpoint was objective response rate (ORR) as assessed by independent central review.
Key Efficacy Results (Median Follow-up 8.9 Months)
- Objective Response Rate (ORR):
- 5.4 mg/kg Group: 37.8%
- 6.4 mg/kg Group: 27.5%
- Median Progression-Free Survival (PFS):
- 5.4 mg/kg Group: 5.8 months
- 6.4 mg/kg Group: 5.5 months
- Median Duration of Response (DOR): 5.5 months for both groups.
Safety Profile
The safety profile favored the lower dose:
- Grade 3+ Adverse Events: 49.4% (5.4 mg/kg) vs. 59.0% (6.4 mg/kg).
- Drug-Induced Interstitial Lung Disease (ILD): 8.4% (5.4 mg/kg) vs. 12.8% (6.4 mg/kg). Most ILD cases were Grade 1 or 2.
Conclusion
The researchers concluded that Enhertu demonstrates significant antitumor activity in HER2-positive metastatic CRC. Based on the risk-benefit profile, 5.4 mg/kg was identified as the optimal dose for this patient population, offering high efficacy with a more manageable safety profile compared to the 6.4 mg/kg dose.
Source: ASCO 2023 - DESTINY-CRC02 Abstract #3501
#ColorectalCancer #HER2Positive #Enhertu #TDXd #DESTINYCRC02 #CancerResearch #ADC
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