November 27, 2019 , a Japanese pharmaceutical company controlled by Swiss pharmaceutical giant Roche, recently announced that the Ministry of Health, Labour and Welfare (MHLW) has granted antibody drug conjugates ( ADC) Polivy (polatuzumab vedotin) is eligible for orphan medicine for diffuse large B-cell lymphoma (DLBCL). The eligibility determination is based on the results of a Phase Ib / II clinical study (GO29044 and GO29365) conducted in previously untreated (primary) DLBCL patients and previously treated (treated) DLBCL patients.

Polivy is a first-in-class ADC specifically targeting CD79b. It is a combination of a humanized anti-CD79b antibody and the anti-mitotic agent MMAE (monomethylastatin E). Developed to treat several types of non-Hodgkin's lymphoma (NHL). CD79b is highly specifically expressed in most types of B-cell NHL, making it a promising target for the development of new therapies. polatuzumab vedotin targets binding to CD79b and destroys these B cells, minimizing the impact on normal cells while maximally destroying cancer cells.

Polivy was developed by Roche-based Genentech using ADC technology from Seattle Genetics. In the United States and the European Union, polatuzumab vedotin has been granted orphan drug status for DLBCL, and has been awarded breakthrough drug status (BTD) and priority drug status (PRIME).

In the United States, polivy received accelerated FDA approval in June this year in combination with bendamustine and Rituxan (Meluwa, generic name: rituximab, rituximab) for relapses that have previously received at least 2 therapies Or treatment of patients with refractory diffuse large B-cell lymphoma (R / R DLBCL).

It is worth mentioning that Polivy is the first chemoimmunotherapy approved by the FDA for R / R DLBCL, which can significantly improve the clinical outcome of patients compared with commonly used treatment regimens. DLBCL is an aggressive blood cancer that usually becomes more difficult to treat with each relapse.

In November of this year, the combined use of Polivy and BR also received positive review from the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) for conditional approval for R / R DLBCL patients who are not suitable for hematopoietic stem cell transplantation. the treatment. CHMP's comments have been submitted to the European Commission (EC) for review, and a final decision on Polivy's conditional marketing authorization is expected within the next 2 months.

DLBCL is a histological subtype of non-Hodgkin's lymphoma (NHL) and is classified as an aggressive disease. DLBCL is the most common NHL, accounting for 30-40% of the NHL. DLBCL often occurs in middle-aged and elderly people, mainly in people over 60 years of age. The median age at diagnosis was reported to be 64 years.

Rituxan (Rituxan) combined with chemotherapy is the standard first-line treatment for DLBCL; however, approximately 40% of patients relapse due to insufficient treatment response. In addition, although autologous stem cell transplantation (ASCT) is recommended for patients with relapsed or refractory DLBCL, about half of patients cannot undergo ASCT due to failure of salvage chemotherapy before ASCT. In addition, due to age or complications, there is currently no standard treatment plan for patients who are not eligible for ASCT.

Positive comments from the FDA to accelerate the approval of Polivy and the recommendation of CHMP are based on data from a global phase Ib / II clinical study, GO29365. The Phase II part of the study randomly assigned 80 patients with over-pretreated R / R DLBCL to two regimens: (1) polatuzumab vedotin + bendamustine + rituximab (PBR); (2) benzene Damustine + Rituximab (BR). The median number of patients previously treated was 2 (range 1-7 in the PBR regimen, range 1-5 in the BR regimen).

It is worth mentioning that this is the first and only randomized and pivotal clinical study showing that the response rate of R / R DLBCL patients who are not suitable for hematopoietic stem cell transplantation is higher than BR (a commonly used treatment regimen). The results showed that the complete response rate of the PBR group reached 40% (n = 16/40, 95% CI: 25-57), and the BR group was only 18% (n = 7/40, 95% CI: 7-33) ).

In addition, the study also showed that the objective response rate at the end of treatment in the PBR group was 45% (n = 18/40, 95CI: 29-62), and the BR group was only 18% (n = 7/40, 95% CI : 7-33). In terms of duration of response (DOR), 64% (n = 16/25) of the patients who achieved complete remission in the PBR regimen had a DOR of 6 months or more and 48% (n = 12/25) of patients had a DOR of 1 year or more. The proportion of patients achieving complete response in the BR regimen was only 30% (n = 3/10) and 20% (n = 2/10), respectively.

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