Breakthrough Clinical Results
Legend Biotech announced new data on CARVYKTI® (ciltacabtagene autoleucel), a CAR-T therapy for multiple myeloma, to be presented at ASCO and EHA. Long-term data from the CARTITUDE-1 study shows patients remaining alive and progression-free for over 5 years after a single infusion. CARTITUDE-4 data demonstrates improved progression-free and overall survival in key subgroups compared to standard of care. Preliminary Phase 1 results for LB2102 (lung cancer) and LB1908 (gastroesophageal cancer) will also be presented at ASCO. Data on LB2102 was previously presented at the ASGCT Annual Meeting.
Key Highlights
- Long-term CARTITUDE-1 data shows sustained remission in heavily pre-treated multiple myeloma patients.
- CARTITUDE-4 data shows improved survival with CARVYKTI® versus standard of care in multiple myeloma subgroups.
- Preliminary Phase 1 data on LB2102 (lung cancer) and LB1908 (gastroesophageal cancer) will be presented at ASCO.
- Over 6,500 patients have been treated with CARVYKTI® to date.
Incidence and Prevalence
Global Incidence and Prevalence of Multiple Myeloma
Multiple myeloma (MM) has an incidence of 4-6/100,000 inhabitants and is a fairly frequent malignancy of B cells with incidence increasing markedly with age.
MM represents ~1% of all cancers and is the second most common hematologic malignancy worldwide. Incidence is at least two times higher in Blacks/African Americans compared to Whites, and Hispanics/Latinxs are among the youngest patients diagnosed with the disease.
China-Specific Data (2012-2016)
- Crude prevalence: 6.88 per 100,000 population (95% CI, 5.75-8.00)
- Crude incidence: 1.60 per 100,000 person-years (1.28-1.92)
- Standardized prevalence: 5.68 (5.64-5.72)
- Standardized incidence: 1.15 (1.11-1.19)
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Higher rates in males than females:
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Prevalence: 7.89 vs. 5.79
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Incidence: 1.84 vs. 1.30
- Mean age of MM patients: 57.9 (14.4) years
- Prevalence peaked between 55-74 years for both genders
- Women aged 55-59 had significantly high incidence of 5.53 (4.98-6.11)
- Prevalence and incidence significantly lower than North America, Australia, and Western Europe but in same range as Japan or Korea
With the aging population in China, the incidence of MM is on the rise.
Racial/Ethnic Differences
In a study of 495 MM patients: - Hispanic (n=45) and non-Hispanic Black (n=52) individuals had earlier age of onset than non-Hispanic White (n=398) individuals (53 and 57 vs. 63 years, respectively, P<.001).
Drug used in other indications
Based on the provided context, I cannot offer any information about CARVYKTI® (ciltacabtagene autoleucel) being trialed for indications other than multiple myeloma, as the context only mentions this therapy in relation to multiple myeloma treatment.
The context specifically indicates that:
- CARVYKTI® (cilta-cel) has been approved to treat multiple myeloma patients who have been exposed to at least 1 proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
- Cilta-cel is described as a BCMA-targeted CAR T cell product approved for heavily pretreated multiple myeloma patients
- It is characterized as "a second-generation CAR-T cell with double B cell maturation antigen (BCMA) targeting binding domains" that showed "an 88% overall response rate (ORR) in patients with relapsed/refractory multiple myeloma"
For multiple myeloma trials, several intervention models were identified:
- Triplet regimens versus doublet regimens
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Immunotherapy approaches including:
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Cell-based immunotherapy (CAR T-cells)
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Monoclonal antibody-based immunotherapy
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Targeting key markers: CD38, SLAMF7, and BCMA
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CAR-T therapy trials including:
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KarMMa trial for idecabtagene vicleucel (ide-cel)
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CARTITUDE-1 trial for ciltacabtagene autoleucel (cilta-cel)
- Stem cell transplantation approaches
- Bortezomib therapy protocol