Monday, July 15, 2024

Rare Lymphoma Treatment: Daiichi Sankyo’s Ezharmia Approved in Japan

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Rare lymphoma has led to Daiichi Sankyo achieving a second approval in Japan for its first-in-class dual EZH1 and EZH2 inhibitor, Ezharmia (valemetostat tosylate), as a treatment for relapsed or refractory peripheral T-cell lymphoma (PTCL). This approval follows its previous clearance in Japan in 2022 for relapsed or refractory adult T-cell leukemia/lymphoma (ATL). Ezharmia remains the first and only drug in its class to be approved globally.

PTCL, a group of rare and aggressive blood cancers, accounts for about 10% to 15% of all non-Hodgkin lymphoma (NHL) cases in Japan. In comparison, ATL is less common. Worldwide, approximately 553,000 new cases of NHL were diagnosed in 2022, with PTCL being more prevalent in Asia than in other parts of the world. Most PTCL patients experience disease progression following initial treatment with a multi-drug chemotherapy-based regimen, with a median overall survival of about 5.8 months following relapse.

Japanese Approval of Ezharmia for Rare Lymphoma Based on Positive Phase 2 Trial Results

The Japanese approval of Ezharmia is based on the results of the international VALENTINE-PTCL01 phase 2 trial. The trial demonstrated an objective response rate (ORR) of 43.7% with Ezharmia, with 52 out of an evaluable study population of 119 subjects showing responses, including 17 complete responses and 35 partial responses.

Ezharmia is also being tested for B-cell lymphomas in the phase 2 VALYM trial, with ongoing or planned studies for its use as a combination therapy for solid tumors. The drug is in development for markets outside Japan as well. Other EZH-targeting drugs have been developed, but most selectively target the EZH2 receptor, unlike Ezharmia, which targets both EZH1 and EZH2.

Rare Lymphoma

Selective EZH2 Inhibitors for Rare Lymphoma Include Approved Tazverik and Candidates from Pfizer and Jiangsu Hengrui Medicine

Among these selective EZH2 inhibitors is Ipsen/Epizyme’s Tazverik (tazemetostat), which has been approved in the US for relapsed or refractory follicular lymphoma patients with an EZH mutation and metastatic or locally advanced epithelioid sarcoma that cannot be treated with surgery. Pfizer’s PF-06821497 and Jiangsu Hengrui Medicine’s SHR2554 are other selective EZH2 candidates currently in early-stage testing.

In related news, China’s National Medical Products Administration (NMPA) has granted approval to Dizal’s selective JAK1 inhibitor, golidocitinib, as a second-line treatment for PTCL. This marks the first global approval of a drug in this class for PTCL, based on the results of the JACKPOT8 Part B study, which showed an ORR of 44.3% and a complete response rate of 23.9%.

Dizal, a joint venture established in 2017 by UK pharma group AstraZeneca and the Chinese Future Industry Investment Fund (FIIF), also received NMPA approval last year for its selective EGFR inhibitor, sunvozertinib, for non-small cell lung cancer (NSCLC) patients with EGFR Exon 20 insertions.

The approval of Ezharmia in Japan and the developments in the treatment of PTCL highlight the ongoing efforts to address the unmet needs of patients with these rare and aggressive cancers. Ezharmia’s unique dual inhibition mechanism and its expanding list of indications signify its potential to become a significant therapeutic option in oncology. With the continuous advancements in targeted therapies and the growing understanding of molecular pathways in cancer, patients with conditions like PTCL and other rare lymphomas may see improved outcomes and better quality of life. The collaboration between companies like Daiichi Sankyo and regulatory bodies exemplifies the commitment to bringing innovative treatments to patients in need, further advancing the field of oncology.

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Resource: Daiichi Sankyo, June 24, 2024

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