2021 CSCO lymphoma diagnosis and treatment guidelines are updated to include verbutuximab

On April 23-24, 2021, the 2021 Chinese Society of Clinical Oncology (CSCO) Guidelines will be held in Beijing.

The CSCO lymphoma diagnosis and treatment guidelines have been updated from chapter additions and deletions, general principles and treatment parts.

As the world’s first and only CD30 antibody-conjugated drug (ADC), verbutuximab has new features in systemic anaplastic large cell lymphoma (sALCL) and classic Hodgkin’s lymphoma (cHL).
Increase recommendation.

Update points of the CSCO Lymphoma Diagnosis and Treatment Guidelines "CSCO Lymphoma Diagnosis and Treatment Guidelines (2021 Edition)" The update points are as follows.

01 chapter additions and deletions "CSCO Lymphoma Diagnosis and Treatment Guidelines (2021 Edition)" newly added 5 chapters, namely "High-grade B-cell lymphoma" chapter, "Primary mediastinal (thymic) large B-cell lymphoma" chapter, "Protocol The chapters on “Diffuse Large B-Cell Lymphoma of the Breast”, the “Primary Diffuse Large B-Cell Lymphoma of the Testis” and the “Castleman Disease” chapter; one chapter is deleted, that is, “18F-FDG PET-CT in Lymphoma "Applications" chapter (this part is set up in a separate volume).

02 General Provisions In the general provisions, hepatitis B virus related content is detailed.

03 Treatment of peripheral T-cell lymphoma (PTCL): For newly-treated patients, ALK-positive or negative anaplastic large cell lymphoma (ALCL), the level II recommendation is to add "Vibtuximab + CHP".

For patients with relapsed and refractory sALCL, regardless of whether they are suitable for transplantation, the level I recommendation is to add "Vibtuximab".

HL: For newly-treated patients, level II recommends adding "Vibtuximab + AVD × 6 cycles ± radiotherapy".

For relapsed and refractory patients, the level II recommendation is to add "Vibtuximab"; the level III recommendation is to add "Vibtuximab + Nivolumab".

(Note: The approved indications of verbutuximab in China are CD30-positive relapsed or refractory sALCL and cHL adult patients, and CD30-positive primary skin anaplastic large cells that have received systemic treatment in the past Adult patients with lymphoma (pcALCL) or mycosis fungoides (MF)) For diffuse large B-cell lymphoma (DLBCL), relapse and refractory treatment strategies have been added.

For the first and ≥2 recurrence/progression patients, the newly added level II experts recommend "CAR-T, R2, iR2, BTK inhibitors, etc.
".

Mantle cell lymphoma (MCL): For newly treated patients, the "R-bendamustine/R-high-dose cytarabine" regimen is added as a level II recommendation.

For patients with relapse and refractory treatment, "Obutinib" is recommended for level I; "Ibrutinib + Venecla" and "CAR-T cell therapy" are recommended for level III.

For chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), it is emphasized that the staging of SLL is based on the Lugano staging.

In the treatment of CLL/SLL, for newly-treated patients with indications for treatment and del(17p)/p53 gene mutations, the level I recommendation is to add "Zebutinib".

For relapsed and refractory patients, the level I recommendation is to add "Zebutinib, Obutinib, Venecla + Rituximab".

The world’s first CD30-targeted ADC, vebutuximab, is favored by the guidelines.
Vebutuximab is made up of the CD30-targeting monoclonal antibody cAC10 and the anti-microtubule drug monomethyl auristatin E (MMAE).
The ADC connected by the peptide linker remains stable in the blood.

Vebutuximab is mainly targeted to bind CD30+ tumor cells to release MMAE, inhibit microtubule polymerization, arrest the G2/M phase and cause apoptosis, and cause bystander effect to kill neighboring cells to achieve a precise fight against tumors.
Effect [1,2]. In the latest edition of the CSCO lymphoma diagnosis and treatment guidelines this year, the recommendations for patients with relapsed/refractory sALCL or cHL are as follows, and verbutuximab is included: Table 1.
The guidelines recommended treatment strategy table for patients with relapsed/refractory PTCL 2.
The guidelines recommended treatment strategies for patients with relapsed/refractory cHL.
The results of the Vibutuximab study fully reflect the benefits of treatment.
At present, the treatment options for relapsed/refractory sALCL and cHL are limited, and the survival status of patients is not optimistic.

Research data shows that after first-line treatment of sALCL patients, about 40% to 64% of patients still have recurrence or progression [3], and the prognosis of chemotherapy after recurrence is poor.

According to a retrospective analysis, after chemotherapy in patients with relapsed/refractory sALCL, the median progression-free survival (PFS) was only 1.
8 months, and the median overall survival (OS) was only 3.
0 months [4] .

In addition, the treatment options for relapsed/progressive HL patients are limited and the prognosis is poor, and more treatment options are urgently needed.

The pivotal trial of vebutuximab has verified its efficacy [5]: The SG035-0004 study showed that in 58 patients with R/R sALCL, the objective response rate (ORR) of vebutuximab treatment was Up to 86%, the 5-year OS rate is 60%.

The SG035-0003 study indicated that the ORR of patients with R/R cHL after vebutuximab treatment of ASCT was as high as 75%, and the complete remission (CR) rate was 33%.

The C25007 study showed that among 60 R/R cHL patients who had received at least one chemotherapy regimen before and were not suitable for stem cell transplantation or multi-drug chemotherapy at the time of starting Vebutuximab treatment, the ORR of Vebutuximab treatment was up to 50%.

In real clinical practice, a real-world study in Japan [6] showed that for patients with relapsed/refractory sALCL and cHL, retreatment with verbutuximab has good efficacy and controllable safety.
The ORR was 70.
0%, the ORR of cHL patients was 52.
9%, the CR rates were 60.
0% and 52.
9%, and most of the adverse events were grade 1 or 2. In addition, a real-world study in Taiwan, China [7] shows that the ORR of verbutuximab for the rescue treatment of relapsed/refractory HL is as high as 73.
7%, the CR rate is 21.
1%, and the safety is good.

References: [1] Pierce JM, Mehta A.
Diagnostic, prognostic and therapeutic role of CD30 in lymphoma[J].
Expert Rev Hematol.
2017;10(1):29-37.
[2] Schirrmann T, Steinwand M, Wezler X, et al.
CD30 as a therapeutic target for lymphoma[J].
BioDrugs.
2014;28(2):181-209.
[3] Savage KJ, et al.
Blood 2008;111:5496-504.
[4 ] Mak V, et al.
J Clin Oncol 2013;31:1970-6.
[5] Instructions for Verbutuximab for Injection.
[6] Fukuhara N, Yamamoto G, Tsujimura H, et al.
Leuk Lymphoma.
2020 Jan;61(1):176-180.
[7] Tien FM, Tsai CH, Liu JH, et al.
J Formos Med Assoc.
2019 Oct;118(10):1466-1470.
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