Seattle Genetics Data Published On North American Subgroup Data from ECHELON-1 Phase 3 Clinical Trial of Adcetris in Newly Diagnosed Advanced Hodgkin Lymphoma.
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- Data from US-based biotechnology company Seattle Genetics, Inc. (NASDAQ: SGEN) ECHELON-1 phase 3 clinical trial has been published online in the journal Clinical Cancer Research, the company said.
The publication, titled "Brentuximab Vedotin Plus Chemotherapy in North American Patients with Newly Diagnosed Stage III or IV Hodgkin Lymphoma," reports data from the North American patient population from ECHELON-1 evaluating Adcetris (brentuximab vedotin) in combination with AVD (Adriamycin, vinblastine and dacarbazine) in newly diagnosed stage III or IV classical Hodgkin lymphoma.
These data were previously presented in a poster presentation at the 2018 American Society of Clinical Oncology annual meeting.
In March 2018, the US Food and Drug Administration approved Adcetris in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL based on the positive results of the ECHELON-1 phase 3 clinical trial.
Adcetris is an antibody-drug conjugate directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival.
Of the 1,334 advanced stage classical HL patients who participated in the ECHELON-1 clinical trial, 497 patients were treated in North America, with 250 patients in the Adcetris plus AVD arm and 247 patients in the ABVD control arm.
The manuscript presents the North American results which include:
A pre-specified sensitivity analysis showed per Independent Review Facility assessment, the two-year modified progression-free survival rate for patients in the Adcetris plus AVD arm was 84.3% compared to 73.7% in the control arm (HR 0.596; 95% CI: 0.40, 0.90), which corresponds to a difference of 10.6%.
On the Adcetris plus AVD arm, peripheral neuropathy events were observed in 80 % of patients compared to 56% on the ABVD arm.
In the Adcetris plus AVD arm, the majority of peripheral neuropathy events were Grade 1 or 2 (41 % and 21 %, respectively).
Grade 3 events were reported in 17% of patients. In the ABVD arm, Grade 3 events were reported in less than 1% of patients.
There were no Grade 4 events on either arm. Across both arms of the study, approximately 75% of the patients with peripheral neuropathy reported resolution or improvement at last follow-up.
Febrile neutropenia during treatment was reported in 20 % of patients in the Adcetris plus AVD arm compared with 9% in the ABVD arm. In the Adcetris plus AVD arm, 14% (35 patients) received primary prophylactic G-CSF within five days of starting treatment and 9% (three patients) reported febrile neutropenia.
Pulmonary toxicity was reported in 3% of patients in the Adcetris plus AVD arm versus ten % of patients in the ABVD arm.
Grade >=3 events were reported in 2% versus 6% of patients, in the Adcetris plus AVD and ABVD arms, respectively.
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma.
Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell.
The Reed-Sternberg cell expresses CD30.
According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2018 and more than 1,000 will die from the disease.
Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease.
According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.
Adcetris is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas.
These include three completed phase 3 trials: ECHELON-2 in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and Alcanza in cutaneous T-cell lymphoma. The phase 3 CHECKMATE 812 trial of Adcetris in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.
Adcetris is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E, utilizing Seattle Genetics' proprietary technology.
The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalisation into CD30-expressing tumor cells.
Seattle Genetics is an emerging multi-product, global biotechnology company that develops and commercialises therapies targeting cancer.
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|Date:||Jan 11, 2019|
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