AstraZeneca, Daiichi Sankyo drug, Keytruda combo shows promise in early stage lung cancer trial
gorodenkoff

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) said their medicine datopotamab deruxtecan (Dato-DXd) in combination with Merck's (MRK) Keytruda (pembrolizumab), with or without platinum chemotherapy, showed promising clinical activity and a tolerable safety profile in certain patients with a type of lung cancer.
The study, dubbed TROPION-Lung02, evaluated the drug combination in patients with previously untreated or pretreated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.
The companies said that an interim analysis of the ongoing study showed an overall response rate (ORR) in the overall population of 37% (median follow-up of 6.5 months) of 38 patients receiving the (Dato-DXd + Keytruda) doublet therapy and an ORR of 41% (median follow-up of 4.4 months) of 37 patients receiving the triplet therapy (Dato-DXd + Keytruda + platinum chemotherapy).
A disease control rate (DCR) of 84% was seen with both the doublet and triplet combination therapy in the overall population which comprised both first-line and second-line settings, the company said in an Aug. 9 press release.
In previously untreated patients, ORRs of 62% (eight of the 13 patients receiving doublet therapy) and 50% (10 of 20 patients receiving triplet therapy) were seen. Eight partial responses (PRs) were seen in patients on doublet therapy and 10 PRs (three pending confirmation) were seen in patients receiving triplet therapy.
Meanwhile, a DCR of 100% was seen with doublet therapy and a DCR of 90% was seen with the triplet therapy.
The companies said Grade 3 or greater treatment-emergent adverse events (TEAEs) happened in 40% and 60% of patients in the doublet and triplet groups, respectively.
The most frequent TEAEs of any grade were soar mouth, nausea, decreased appetite, fatigue and anemia.
There were four interstitial lung disease events determined as drug-related across both cohorts. Two were determined as grade 1/2 and the remaining two were adjudicated as grade 3.
The companies noted that therapy discontinuations due to adverse events occurred in less than 21% of patients and Dato-DXd dose discontinuation occurred in 13% of patients.
Combinations with Dato-DXd showed a tolerable safety profile, which supports further evaluation in ongoing studies, the companies added.
As per the companies, Dato-DXd is a specifically designed TROP2 directed DXd antibody drug conjugate.