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Bristols’ DLBCL CAR-T Therapy -Lisocabtagene Maraleucel (JCAR017) Future Strategy & Latest Events

Liso-cel Strategy

Lisocabtagene maraleucel, also known as liso-cel and JCAR017 is a 4-1BB-based second generation CAR-T therapy, that contains a distinct IgG4-based hinge. The therapy is a key pipeline asset which Bristol-Myers picked up through its takeover of Celgene, originally belongs to Juno Therapeutics.

On July 17, 2020, Bristol’s liso-cel was validated for MAA by EMA for Relapsed or refractory (R/R) diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade 3B. The Therapy is also under review by FDA for Relapsed or refractory (R/R) large B-cell lymphoma with extended PDUFA date of 16th November 2020. 

Roughly 30% to 40% of patients develop relapsed/refractory DLBCL, which, in addition to being associated with a significantly increased risk of morbidity and mortality, presents unique treatment challenges.

Latest Events

DRUG

INDICATION

STAGE

NEWS

Liso-cel (JCAR017) – TRANSCEND NHL 001 study and additional TRANSCEND WORLD 001

Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade 3B

MAA Validation

From 17 July 2020 onwards the centralized review process of the EMA begins

JCAR017 in combination with durvalumab – PLATFORM

Non-hodgkin Lymphoma

Phase 1b

Phase 1b initiated.

Liso-cel (JCAR017) – TRANSCEND NHL-001

Relapsed or refractory (R/R) large B-cell lymphoma

PDUFA priority review

PDUFA date under priority review extended by three months to November 16, 2020.

Liso-cel (JCAR017) – TRANSCEND CLL-004

Chronic Lymphocytic Leukemia (CLL)

Phase 1

Phase 1 updated data at ASH December 8, 2019. 45.5% CR; 81.5% ORR.

Liso-cel (JCAR017) – TRANSCEND OUTREACH

Relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL)

Phase 2

Phase 2 trial initiated 4Q 2018.

CAR-T Therapy: Kymriah vs Yescarta vs Liso-cel (JCAR017) on Efficacy & Safety Terms

Liso-cel-Efficacy-Safety-comparison

Liso-cell-Interview

CAR-T Therapy Vein to Vein Manufacturing Turnaround Time of Liso-cell (JCAR017)

Liso-cel-Manufacturing-time

Bristol’s liso-cel CAR-T Therapy Outpatient setting

  • In the TRANSCEND NHL 001 (NCT02631044), PILOT (NCT03483103), and OUTREACH (NCT03744676) studies, results showed that outpatient treatment had comparable clinical outcomes and toxicity as treatment across all patients and data demonstrating the use of machine learning.
    • Suggested feasibility of this approach
    • Potentiating wider use of CAR-T Therapy in DLBCL
“Using a proprietary data integration platform, we’ve been able to deploy machine learning approaches to develop critical insights for our programs including optimize patient selection, rational combinations for platform studies and process improvements that have given rise to our Nex-T products that are now in the clinic. The Nex-T has the potential to markedly impact turnaround time and cost of goods for autologous cell therapy,” Vessey, EVP BMS.
  • Outpatient monitoring involves daily clinical visits or phone calls for the first 7 days, then at least twice a week for up to 30 days
  • The patient should stay close to the treatment center so that they can be quickly admitted with signs of symptoms.

Liso-cel-Interview

CAR-T Therapy JCAR017 Risks related to Outpatient Setting

  • Timely delivery of medications for the treatment of side effects of CAR-Ts in an outpatient setting
  • Capacity building for outpatient CAR-T therapy involves the training of hospital nurses, medical assistants and consultancy service

JCAR017-Terms of cost structures amidst COVID-19

  • Could be redefined in the form of bundled payment

Submit your Request for Proposals at bd@mellalta.com

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