Unmet Need / FL
What's the estimated amount of new cases of NHL in 2020?
77,240
What is YESCARTA® (axicabtagene ciloleucel) FL indication?
indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
What was the ZUMA 5 Study?
A phase 2, multicenter, single-arm, open-label study evaluating the efficacy and safety of YESCARTA in adults with r/r FL after ≥2 lines of systemic therapy
• 146 patients received YESCARTA and were evaluated for safety
• 81 patients with r/r FL were evaluable for efficacy
• Median age: 62 years (range: 34 to 79 years)
What is the ORR and CR for the Primary group?
ORR - 91 %
CR - 60%
Overall incidence of CRS Rates?
Grade 3 or higher?
Overall incidence: 84%
Grade ≥3* incidence: 8%
They decrease Substantially
What are the Black Box Warnings for YESCARTA®?
• Cytokine Release Syndrome (CRS)
Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
• Neurologic toxicities
Provide supportive care and/or corticosteroids as needed.
• YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program
What were the endpoints for Zuma 5?
Primary
Efficacy Based on ORR (CR + PR) and DOR
Selected Secondary Endpoints
Safety
What is the ORR and CR for All Leukapheresed Patients?
ORR - 89 %
CR - 62%
CRS Median time to onset?
CRS Median duration?
Median time to onset: 4 days (range: 1 to 20 days)
Median duration: 6 days (range: 1 to 27 days)
What is the 2-YEAR OVERALL SURVIVAL IN NEWLY DIAGNOSED PATIENTS TREATED WITH FIRST-LINE CHEMOIMMUNOTHERAPY who relapse within 24 months?
64% in patients who relapsed within 2 years of diagnosis
How long does it take to manufacture the CART cells?
What is the manufacturing success rate?
17 Days
100% Success Rate
What were the Inclusion and Exclusion criteria for the study?
Eligibility
r/r FL after ≥2 lines of systemic therapy including the combination of an anti-CD20 monoclonal antibody and an alkylating agent
Excluded
Patients with active or serious infections, transformed lymphoma or other aggressive lymphomas, prior allogeneic HSCT, or CNS involvement
What is the ORR for KEY R/R FL SUBGROUPS?
5 sub groups
90% Disease progression within 6 months of most recent regimen
92% FLIPI score ≥3
95% High tumor burden
89% Disease progression within 24 months of first anti-CD20 combination therapy
92% Received prior PI3K inhibitor
Signs and Symptoms of CRS?
Fever (80%)
Chills (21%)
Hypotension (38%)
Tachycardia (29%)
Hypoxia (21%)
Headache (13%)
What is the 2-YEAR OVERALL SURVIVAL IN NEWLY DIAGNOSED PATIENTS TREATED WITH FIRST-LINE CHEMOIMMUNOTHERAPY who do not relapse within 24 months?
98% in patients who did not relapse within 2 years of diagnosis
Yescarta Molecule
What is the Target for Yescarta?
What is the costimulatory domain?
What is the activation domain?
CD -19
CD - 28
CD - 3Z
What were KEY CHARACTERISTICS OF THE ZUMA-5 POPULATION (N=81)?
≥ 4 prior lines of therapy (46%)
Received prior PI3K inhibitor (31%)
Disease progression within 6 months of most recent regimen (72%)
Disease progression within 24 months of first anti-CD20 combination therapy (56%)
What is the median DOR?
What is the median follow up for DOR?
NR
14.5 Months
Incidence of Neurologic toxicities?
Grade 3 of higher?
Overall incidence: 77%
Grade ≥3* incidence: 21%
What FACTORS are ASSOCIATED WITH POOR OUTCOMES IN FL?
High FLIPI Score >3
High Tumor Burden
What should long term monitoring be for the community oncologist after treatment?
▸ Prolonged cytopenias
▸ Hypogammaglobulinemia
▸ Secondary malignancies
▸ Serious infections
What are the signs and symptoms of Neurologic Toxicity?
Encephalopathy (53%)
Headache (45%)
Tremor (31%)
Dizziness (20%)
Aphasia (15%)
Delirium (16%)
Insomnia (11%)
Based on Kaplan-Meier estimate, What are the response rates at 12 Months? & 18 Months?
76% at 12 Months
74% at 18 Months
What is the median time to onset of Neuro Tox?
What is the median duration of Neuro Tox?
Median time to onset: 6 days (range: 1 to 79 days)
Median duration: 16 days