The efficacy is the key to the success of innovative drugs.

On June 4th, Genscript Bio (1548.HK, referred to as "Genscript") announced that its subsidiary, Legend Biotech (LEGN.O), released the results of Phase 2 CARTITUDE-2 (Siltuximab) Cohort D study for the treatment of multiple myeloma patients for the first time at the ASCO Annual Meeting.

The results showed that the total remission rate of patients treated with Siltuximab was as high as 94%. Prior to this, Siltuximab's overall remission rate for fourth-line and above treatment was 97%.

This means that Siltuximab also has a significant effect in frontline treatment. The market reacted positively, and Genscript's closing on June 4th rose by 10.57%.

According to Legend Biotech's plan, clinical trials of Siltuximab for first-line treatment of multiple myeloma are currently underway.

With the opening of the sales space of Siltuximab, Genscript may be close to turning a profit.

The total remission rate reached 94%.

As the first CAR-T product approved and listed in the United States from China, the first action of Siltuximab has attracted much attention.

In February 2022, Siltuximab was approved for listing in the United States and used to treat relapsed or refractory multiple myeloma (MM), and these patients have received at least fourth-line treatment, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies (referred to as "fourth-line and above therapy").

As one of the common malignant tumors in the blood system, MM may cause various symptoms such as kidney damage and systemic muscle weakness. It is more common in the elderly and is currently an incurable disease in clinical practice. CAR-T is currently one of the methods that can be used to treat MM with certain remission effects.

This year, Legend Bio pushed Siltuximab to frontline treatment again.

In April, the FDA approved Siltuximab for second-line treatment of multiple myeloma, becoming the first and only B-cell maturation antigen (BCMA) targeted therapy approved for second-line treatment of patients with relapsed or refractory multiple myeloma.

The CARTITUDE-2 clinical trial of Siltuximab included in the ASCO oral report is an ongoing Phase 2 multi-cohort study designed to evaluate the safety and efficacy of Siltuximab in various clinical settings (Cohorts A, B, C, D, E, F, and G, H).

The results of Cohort D revealed that patients receiving Siltuximab combined with or without lenalidomide maintenance treatment after frontline treatment with autologous stem cell transplantation and incomplete remission could achieve deep and lasting remission.

Specifically, in a median follow-up of 22 months, the total remission rate of patients treated with Siltuximab reached 94%, 16 patients achieved complete remission or better, and in 15 patients with measurable residual disease (MRD), 80% were negative for 10-5 MRD. The median duration of remission has not been reached. The median time to first remission was one month, and the progression-free survival (PFS) and overall survival (OS) at 18 months were both 94%.

Simply put, about 94% of patients treated with Siltuximab did not experience disease progression or worsening within 18 months after treatment.

"Patients who did not achieve complete remission after autologous stem cell transplantation may experience shorter duration of sustained remission in future treatments. This research result shows encouraging efficacy and demonstrates the potential benefits that CARVYKTI may bring to this patient population." Dr. Melissa Alsina, Head of Myeloma BMT-CI Project at H. Lee Moffitt Cancer Center and Research Institute in the United States said.

It is worth mentioning that the overall remission rate of Siltuximab for fourth-line and above treatment is 97%.

This data indicates that Siltuximab is still effective in frontline treatment.

This data suggests that idecabtagene vicleucel still maintains its effectiveness in advancing frontline treatment.

Legend Biotech also indicated that clinical trials of ciltacabtagene autoleucel for first-line treatment are currently underway.

"These results show a significant impact of CARVYKTI on multiple myeloma patients who received treatment earlier than ever before. We believe that CARVYKTI can produce deep and lasting remission earlier in the treatment pattern of multiple myeloma. Therefore, we are conducting a Phase III study to determine whether patients will benefit from CARVYKTI in first-line treatment," said Mythili Koneru, Chief Medical Officer at Legend Biotech.

Sales growth is expected.

Whether it can advance to the front line is viewed as the key to opening up sales space for ciltacabtagene autoleucel.

Referring to Yescarta, the world's first CAR-T product with annual sales exceeding $1 billion, one of the magic factors is to push the scope of indications to front-line treatment.

As the world's first CAR-T drug approved for the treatment of certain non-Hodgkin's lymphomas, the indications of Yescarta cover large B-cell lymphoma (LBCL) that is resistant to first-line chemotherapy or relapses within 12 months after first-line chemotherapy, as well as LBCL that relapses after two or more lines of or refractory to the second line of comprehensive therapy, follicular lymphoma.

In other words, the indications of Yescarta basically cover first-line, second-line and above relapsed or refractory LBCL, which has also promoted the global sales growth of Yescarta.

In 2019, the sales of Yescarta, which was only applicable to second-line and above relapsed or refractory LBCL, were $456 million; but by 2023, the sales of Yescarta with multiple indications had exceeded the $1 billion mark, reaching $1.498 billion.

With the expansion of the indications, it remains to be seen whether ciltacabtagene autoleucel can achieve more significant growth, and the market is eagerly watching.

With the continuous output of ciltacabtagene autoleucel, whether Kite Pharma can get rid of the situation of losses, has attracted much attention.

Kite Pharma mainly relies on life science services and product revenue, such as gene synthesis, and achieved a revenue of $413 million in 2023, accounting for 48.2% of the total revenue. However, the business growth is limited, with only a 14.53% year-on-year growth in 2023.

In contrast, the revenue of the cell therapy business, including ciltacabtagene autoleucel, grew significantly, with revenue of $285 million in 2023, a year-on-year increase of 143.7%, accounting for 33.9% of the total revenue.

Moreover, most of Kite Pharma's research and development expenses are also invested in the research and development of ciltacabtagene autoleucel, leading to its persistent loss in recent years.

In 2023, Kite Pharma's research and development expenses were $433 million, and the net loss during the same period was $95 million.

"Increase investment in talent, hire experienced personnel, and provide them with competitive compensation and equity-based stock compensation." Kite Pharma said, "Continuous investment in the research and development of cilta-cel (ciltacabtagene autoleucel) (including increasing the patient enrollment rate of cilta-cel Phase III clinical trials) and other research and development pipeline projects."

Now, with the continuous commercialization of ciltacabtagene autoleucel, Kite Pharma may be getting closer and closer to its goal of profitability.