Equipped with two new drugs this year alone

Tecvayli, the first bispecific antibody for multiple myeloma, approved on the 26th

March 2nd New drug following CAR-T treatment Kavicty

Janssen challenges with a new mechanism, BMS widening the gap with maintenance therapy Janssen has added a new drug for multiple myeloma in Korea.

 

This is the second permit this year.

 

It is noteworthy whether Janssen will change the multiple myeloma market where BMS dominates with Celgene.

 

On the 26th, the Ministry of Food and Drug Safety approved Janssen’s Tecvayli as a fourth or higher treatment.

 

Tecvayli is indicated for use as monotherapy in adult patients with relapsed or refractory multiple myeloma who have received at least three lines of therapy, including proteasome inhibitors, immunosuppressants, and anti-CD38 monoclonal antibodies.

 

Tecvayli is Korea's first multiple myeloma bispecific antibody.

 

It double-targets the B-cell maturation antigen (BCMA), which is overexpressed on multiple myeloma cells, and the CD3 receptor, which is expressed on the surface of T cells.

 

When this antibody binds to BCMA and CD3, lysis and death of BCMA-expressing myeloma cells are induced by activated T cells.

 

The study that served as the basis for Tecvayli's approval was the MajesTEC-1 study, a phase 1/2 clinical trial.

 

As a result of evaluating efficacy in 165 patients, Tecvayli recorded an ORR of 63% in patients who failed 3 or more treatments.

 

32.7% of patients presented with sCR.

 

The number of patients with CR and VGPR was also 6.7% and 19.4%, respectively.

 

The average time from the administration of Tecvayli to the first response was 1.2 months.

 

The response lasted 18.4 months.

 

Janssen's aggressive move in multiple myeloma continues.

 

Following the CAR-T treatment Kavicty in March, Tecvayli was installed with two new drugs this year alone.

 

Kavicty is the second CAR-T treatment to appear in Korea.

 

This is the first CAR-T with multiple myeloma as an indication.

 

Unlike existing multiple myeloma treatments, Kavicty inserts genetic information capable of recognizing BCMA into the patient's immune cells and then injects these T cells back into the patient's body.

 

Initially, Kavicty was approved for use as a fifth-line or higher treatment, and the number of patients for which it could be used was very limited.

 

Recently, a new clinical presentation prepared the basis for expanding the scope.

 

These are the results of the phase 3 clinical CARTITUDE-4 study presented at ASCO 2023 held in June.

 

In this clinical trial, standard therapy PVd (Pomalidomide + Bortezomib + Dexamethasone) or DPd (Daratumumab + Pomalidomide + Dexamethasone) was administered to 419 patients with relapsed/Lenalidomide-refractory multiple myeloma who had previously received first- or third-line treatment.

 

Compared to Kavicty.

 

Clinical results showed that Kavicty lowered the risk of disease progression or death by 74% compared to standard therapy.

 

In the primary endpoint, progression-free survival, the Cavikti group recorded 76%.

 

The control group was 49%.

 

The control group's median PFS was recorded at 11.8 months, whereas the Kavicty group had not yet reached the median.

 

As a result of the sub-analysis according to the treatment order, Kavicty proved its potential as a second to fourth-line treatment by improving progression-free survival regardless of the treatment order.

 

Tecvayli, approved this month, is considered a promising global blockbuster.

 

Clarivate, a global academic information service company, predicted earlier this year that Tecvayli will record estimated sales of $1.8 billion (2.2363 trillion won) in 2031.

 

However, as competition in the multiple myeloma treatment market is fierce, the report said that Tecvayli needs to think about ways to increase its utilization if it wants to become a blockbuster new drug.

 

Accordingly, Janssen is seeking a new combination therapy using Tecvayli.

 

It is a method of using it in combination with Talquetamab, a new bispecific antibody drug that has not yet been approved in Korea.

 

Unlike Tecvayli, which simultaneously targets BCMA and CD3, Talquetamab is a novel mechanism that inhibits both GPRC5D protein and CD3 expressed on the surface of specific cancer cells.

 

At the last ASCO, data from phase 1b clinical trials evaluating the combination therapy of the two drugs were also announced.

 

Janssen is trying to transform the multiple myeloma market by adding two new drugs with new mechanisms following the existing drugs, Darzalex and Velcade.

 

Several pharmaceutical companies in Korea are selling multiple myeloma treatments, but BMS is by far the strongest player at this point.

 

BMS has significantly strengthened its multiple myeloma pipeline by acquiring Celgene, which owns Velcade and Pomalyst.

 

The BMS-Celgene acquisition, which took place in 2019, was of an unprecedented scale and was considered the most significant M&A case in the global pharmaceutical industry.

 

At that time, the amount invested by BMS to acquire Celgene amounted to about 83 trillion won.

 

According to IQVIA, a pharmaceutical market research institute, Revlimide has the highest annual sales of 38.6 billion won among domestic multiple myeloma treatments.

 

Amgen's Kyprolis ranked second with 34.5 billion won in sales.

 

Sales of Janssen's Darzalex and Velcade recorded 21.2 billion won and 10.4 billion won, respectively.

 

Darzalex is showing rapid growth but remains in third place.

 

Janssen plans to change the treatment landscape with a new drug with a new mechanism.

 

To this end, efforts are in full swing to raise the treatment order of new drugs to the front stage.

 

The variable is the maintenance regimen of Revlimide.

 

Revlimide, which was the first-line treatment, is widening the gap by moving to maintenance therapy, which is a more advanced treatment.

 

In January of this year, maintenance therapy was also listed on the list of insurance benefits, showing a growing trend.

 

Revlimide sales in the first quarter were 10.4 billion won, up 14% from the previous year.