FDA Approves Legend Bio's First CAR-T Cell Therapy Product, CARVYKTI® (Cedaki Orenza)

On February 28, 2022, local time, Legend Bio (NASDAQ: LEGN) officially announced in Somerset, New Jersey, the United States that its self-developed cell therapy product, Cedar Keorenza (English trade name: CARVYKTI®, is commonly used in English).
ciltacabtagene autoleucel (Cilta-cel for short) was approved by the U.
S.
FDA for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received four or more prior therapies, including Proteasome inhibitors, immunomodulators and anti-CD38 monoclonal antibodies
.

Legend Bio and Janssen entered into an exclusive worldwide license and collaboration agreement in December 2017 to develop and commercialize CARVYKTI®

FDA Immunity

Legend Bio's CARVYKTI® CARVYKTI® was approved by the FDA for the treatment of adult relapsed/refractory multiple myeloma (MM), becoming the first FDA-approved cell therapy product in China and the second in the world Approved CAR-T cell immunotherapy targeting BCMA
.

CAR-T

CARVYKTI® is a chimeric antigen receptor (CAR) T-cell immunotherapy with two single-domain antibodies targeting B-cell maturation antigen (BCMA), administered as a one-time infusion at a recommended dose of 0.
5 per kg body weight ~1.
0×106 CAR-T cells
.

CARTITUDE-1 is an ongoing Phase 1b/2, open-label, single-arm, multicenter study evaluating the safety and efficacy of CARVYKTI® in adult patients with relapsed or refractory multiple myeloma who are Patients received at least 3 lines of prior therapy, including proteasome inhibitors (PIs), immunomodulators (IMiDs), and anti-CD38 monoclonal antibodies
.

Of the 97 patients enrolled in the study, 99% were intolerant to last-line therapy and 88% were refractory to three types of therapy, meaning they did not respond to IMiD, PI and anti-CD38 monoclonal antibodies , or no longer responds

According to the summary data published by the 2021 ASCO , as of September 1, 2020, a total of 97 patients had received cilta cel, and the median number of patients who had previously received treatment was 6 lines
.

The overall response rate as assessed by the independent review committee IRC was 97% (95% CI, 91-99), of which 67% achieved a strict complete response (sCR)

ASCO -5

In terms of safety, grade 3/4 hematological adverse events were ≥20%, the incidence of CRS was 95% (4% for grade 3/4), the median time to onset was 7 days (range 1-12), and the median disease duration 4 days (range 1-14, excluding 1 case of 97 days)
.

Except for one case of grade 5 CRS (hemophagocytic lymphohistiocytosis), CRS disappeared in all patients

According to newly published data, 97 R/RMM patients experienced deep and durable responses, with an overall response rate (ORR) as high as 98% (95% CI: 92.
7-99.
7), and 78% of patients achieved a strict complete response (sCR, 95%CI: 68.
8-86.
1)
.

At a median follow-up of 18 months, the median duration of response (DOR) was 21.

The overall response rate (ORR) was as high as 98% (95%CI: 92.

CARVYKTI® is only available through the Risk Evaluation and Mitigation Strategy (REMS) Restricted Dosing Schedule (CARVYKTI® REMS)
.

Safety information for CARVYKTI® includes Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinson's Disease and Guillain-Barré Syndrome, Hemophagocytic Lymphoprolosis/Macrophages Boxed Warning for Activation Syndrome (HLM/MAS) and Prolonged or Recurrent Cytopenia

infection prevention

Dr.
Ying Huang, CEO & CFO of Legend Bio, said: "Multiple myeloma is still incurable, and patients who have received multiple treatments in the past still face poor prognosis and limited treatment options
.

The approval of CARVYKTI® is of great significance to Legend Bio, which is our The first product to be approved since its inception

Multiple myeloma is a malignant tumor caused by the malignant proliferation of plasma cells in the bone marrow
.

Most patients relapse after initial treatment and have poor prognosis after treatment with major drugs such as immunomodulators, proteasome inhibitors, and anti-CD38 antibodies
.

"For most patients with multiple myeloma, the course of treatment is a cycle of remission and relapse, with fewer patients achieving deep remission after end-line therapy," said CARTITUTE-CARTITUTE-M.
1 Principal investigator Dr.
Sundar Jagannath said
.
"That's why I'm very excited about the results of the CARTITUDE-1 study, which showed that CARVYKTI® provides deep and durable responses and long-term treatment-free intervals even after multiple lines of therapy
.
The approval of CARVYKTI® is expected to address these large and unmet patient needs
.
"

As a personalized therapy, the use of CARVYKTI® requires extensive training, preparation and certification to ensure a positive patient experience
.
Legend and Janssen will launch a phased network of certified treatment centers starting in 2022, expanding production capacity and increasing the availability of CARVYKTI® across the United States, ensuring that CARVYKTI® is available to oncologists and their patients in a reliable and timely manner
.

It is worth mentioning that this result is even better than that of the already approved BCMA CAR-T therapy Abecma.
After Abecma treatment, the overall response rate (ORR) of patients was 72%, and 28% of patients achieved complete response (CR).
, the median time to onset after treatment was 30 days, and the median duration of remission was 11 months
.

It is worth mentioning that this result is even better than that of the already approved BCMA CAR-T therapy Abecma.
After Abecma treatment, the overall response rate (ORR) of patients was 72%, and 28% of patients achieved complete response (CR).
, the median time to onset after treatment was 30 days, and the median duration of remission was 11 months
.

About CARVYKTI® (Cilta-cel, Sidakhi Orenza)

About CARVYKTI® (Cilta-cel, Cedar Keorenx)

Cilta-cel is a chimeric antigen receptor T cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA), which uses a chimeric antigen receptor (CAR) transgene to modify the patient's own T cells, to identify and eliminate BCMA-expressing cells
.
BCMA is mainly expressed on the surface of malignant multiple myeloma B cells, advanced B cells and plasma cells
.
The CAR protein of CARVYKTI® has two BCMA-targeting single-domain antibodies with high affinity for BCMA-expressing cells.
After binding to BCMA-expressing cells, CAR can promote T cell activation and expansion, and then remove target cells
.

In December 2017, Janssen entered into an exclusive worldwide license and collaboration agreement with Legend Bio to develop and commercialize CARVYKTI®
.
In April 2021, Legend Bio announced that it submitted a Marketing Authorization Application to the European Medicines Agency
.
In addition to the Breakthrough Therapy (BTA) granted in the U.
S.
in December 2019, Cilta-cel was included as a "Breakthrough Therapy" in China in August 2020
.
The U.
S.
FDA and European EMA granted Cilta-cel orphan drug designation in February 2019 and February 2020, respectively
.

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