Daiichi Sankyo Co Ltd on Monday said the first patient has been dosed in its Tropion-Lung07 phase 3 trial, which is evaluating a combination of treatments for patients with metastatic non-small cell lung cancer.
The Tokyo-based pharmaceutical company said the trial would specifically evaluate datopotamab deruxtecan (Dato-DXd), in combination with pembrolizumab with or without platinum chemotherapy, in patients with previously untreated advanced or metastatic non-squamous NSCLC.
Datopotamab deruxtecan is a specifically engineered antibody drug conjugate being jointly developed by Daiichi and AstraZeneca PLC.
Nearly half of those with NSCLC are diagnosed at an advanced stage and generally have a poor prognosis, Daiichi said.
‘Metastatic non-squamous non-small cell lung cancer remains a challenge because the majority of patients experience disease progression following their initial treatment, underscoring the need for more effective treatment optionsin the first-line setting,’ said Mark Rutstein, managing director and global head of oncology clinical development at Daiichi.
‘The TROPION-Lung07 trial will assess the potential of the combination of datopotamab deruxtecan and pembrolizumab with and without chemotherapy, to evaluate whether this combination may be a more effective standard treatment option than the current standard of care for patients in the first-line setting.’
Cristian Massacesi, managing director, chief medical officer and oncology chief development officer at AstraZeneca, added: ‘The combination of datopotamab deruxtecan with a checkpoint inhibitor with or
without chemotherapy, has shown increased activity and a manageable safety profile in early trials, including TROPION-Lung02.’
TROPION-Lung07 is the third clinical trial collaboration and supply agreement between Daiichi Sankyo
and AstraZeneca alongside a subsidiary of Merck & Co Inc subsidiary to evaluate the combination of
datopotamab deruxtecan and pembrolizumab.
Previous clinical trial collaboration agreements were entered in October 2021 for the TROPION-Lung08 phase 3 trial and in May 2020 for the TROPION-Lung02 phase 1b trial.
Shares in Daiichi were down 1.4% to JP¥4,274.00 each in Tokyo on Monday afternoon, up 0.6% to 10,690.00 pence per AstraZeneca share in London and up 0.7% to $106.11 per Merck share in New York on Monday morning.
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