Approval overview
On May 16, 2024, the U.S. Food and Drug Administration (FDA) approved tarlatamab-dlle (trade name: Imdelltra), a bispecific T-cell engager, for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has progressed following platinum-based chemotherapy. This drug targets Delta-like ligand 3 (DLL3) and CD3, and exerts an anti-tumor effect by activating T cells.
According to data from the Centre for Health Protection (CHP) of Hong Kong, lung cancer is the leading cause of cancer deaths in Hong Kong. In 2023, a total of 3,880 people died from lung cancer, accounting for 26.1% of all cancer deaths.
Key clinical data (DeLLphi-301 trial)
Research design
Open-label, multicenter trial (NCT05060016), which enrolled 99 patients with extensive-stage small cell lung cancer (ES-SCLC) who progressed following platinum-based chemotherapy
Primary efficacy endpoints
- Objective response rate (ORR):40%（95%CI 31%-51%）
- Median Duration of Response:9.7 months (range 2.7-20.7+ months)
Platinum sensitivity analysis
- Platinum-resistant group (27 cases):ORR 52%（95%CI 32%-71%）
- Platinum-sensitive group (42 cases):ORR 31%（95%CI 18%-47%）
Safety warning (black frame warning)
- Cytokine release syndrome (CRS):May be life-threatening
- Neurotoxicity (including ICANS):Need to be closely monitored
Common adverse reactions (incidence>20%)
- CRS, fatigue, fever, taste impairment
- Decreased appetite, musculoskeletal pain, constipation
- Anemia, nausea
Recommended dosing regimen
- Initial dose：1mg on the first day of the first cycle (1 hour intravenous infusion)
- Follow-up dose：10mg on day 8→ 10mg on day 15→ maintain 10mg every 2 weeks thereafter
Special procedures for approval
- Orbis Project:Simultaneous review with Brazil, Canada, Israel, and the United Kingdom drug regulatory agencies
- Real-time Oncology Review (RTOR):Accelerate the data evaluation process
- Breakthrough Therapy Designation:Completed 1 month earlier than the standard approval time
Status of New Drug Registration in Hong Kong
It is worth noting that the Hong Kong Department of Health has recently approved two new drugs for the treatment of extensive-stage small cell lung cancer for registration under the "1+" mechanism, bringing more treatment options to patients. Hong Kong is planning to establish the "Hong Kong Centre for Regulation of Medicinal Products and Medical Devices" by the end of 2026 and implement a phased autonomous new drug approval mechanism.
FAQ
Q: What is extensive-stage small cell lung cancer?
A: Extensive-stage small cell lung cancer refers to small cell lung cancer where the cancer cells have spread to the opposite lung, outside the chest cavity, or to other organs. According to the Hong Kong Cancer Fund, small cell lung cancer accounts for approximately 15-20% of all lung cancers.
Q: When can this new drug be used in Hong Kong?
A: New medications must go through the registration process with the Hong Kong Department of Health before they can be used in Hong Kong. Patients can consult their attending physician to learn about the latest treatment options.
Q: What is a bispecific T-cell adaptor?
A: This is a new type of immunotherapy drug that can simultaneously bind to specific proteins (DLL3) on the surface of cancer cells and immune cells (T cells), prompting the immune system to attack the cancer cells.
Conditional approval instructions
This accelerated approval is based on ORR and duration of response; final approval requires confirmatory trials to confirm clinical benefit.
Source of information：ASCO Post News Report
Find out more about treatment information：
Contact information
If you or your family members would like to learn more about small cell lung cancer treatment services, please feel free to contact Hong Kong United Oncology Centre. Our professional team will provide you with detailed medical consultations and assist in developing the most suitable personalized treatment plan.
- Telephone：+852 2386 8002
- WhatsApp：+852 5518 2992
- Email：Enquiry@hkuoc.hk
- Address：Rooms 01-06, 20th Floor, 238 Nathan Road, Kowloon (MTR Jordan Station Exit E)
