The HD21 trial’s co-primary endpoints include treatment-related morbidity and progression-free survival. Credit: murat photographer/Shutterstock.

Takeda and Pfizer have announced a positive Phase III HD21 trial, evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy.

The trial has shown superior progression-free survival (PFS) and improved tolerability in patients with newly diagnosed Hodgkin lymphoma.

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Sponsored by the German Hodgkin Study Group (GHSG) and supported by Takeda, the four-year HD21 study is a Phase III, randomised, multi-country, open-label trial.

It compared ADCETRIS combined with BrECADD chemotherapy against the standard eBEACOPP regimen in patients with Stage IIb/III/IV classical Hodgkin lymphoma.

The study met its co-primary endpoints at a preplanned three-year analysis, showing significantly improved safety and non-inferior PFS with the ADCETRIS regimen.

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The HD21 trial’s co-primary endpoints include treatment-related morbidity and progression-free survival, with secondary endpoints covering overall survival and quality of life, among others.

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After 48 months, the BrECADD regimen demonstrated a 94.3% PFS compared to 90.9% with eBEACOPP, with a hazard ratio of 0.66, indicating superior efficacy.

The ADCETRIS combination also resulted in a significant reduction in treatment-related morbidity and adverse events, maintaining a consistent safety profile with no new signals.

Takeda will handle potential regulatory filings based on the HD21 study outside the US and Canada, while Pfizer has commercialisation rights within these regions.

ADCETRIS, an antibody-drug conjugate, is designed to target CD30-positive tumour cells and release the cytotoxic agent MMAE upon internalisation.

Takeda global oncology chief medical officer Awny Farajallah said: “In our ongoing effort to improve outcomes for patients with lymphoma, we’ve partnered with the GHSG on the HD21 study to deepen our understanding of how ADCETRIS could further benefit patients in need of new options.

“We are excited about the impact these results could have on patients with newly diagnosed Hodgkin lymphoma, potentially bringing them an additional ADCETRIS-based combination regimen that may significantly reduce side effects without compromising on efficacy.” 

In a separate announcement, Pfizer shared results from the Phase III CROWN trial of LORBRENA in ALK-positive advanced NSCLC, showing an 81% reduction in disease progression or death compared to XALKORI after a median five-year follow-up.