1/8/2024 0 Comments Checkmate 649On a cross-trial basis zolbetuximab in Spotlight outperformed Opdivo in the Bristol drug’s registrational Checkmate-649 trial on both survival measures – but the comparator in Astellas’s study also outperformed Bristol's. Both measures have been hit, with zolbetuximab plus chemo cutting risk by 25% versus chemo alone. Source: product labels & Asco-GI.įor now Astellas can boast a strongly statistically significant result in the Spotlight population on the trial’s primary endpoint, median PFS, as well as in the key OS secondary. Notes: *setting to which EMA restricted Keytruda's use **trial enrolled patients irrespective of PD-L1 expression ^defined as moderate-to-strong membrane staining in ≥75% tumour cells by IHC. Gastric/GEJ, adeno, Her2-ve, Claudin18.2+ve^ Oesophageal/GEJ, squamous or adeno, PD-L1 ≥10%* Trials in 1st-line gastroesophageal junction (GEJ) cancer ![]() Perhaps some of these questions will be answered, and more detail on safety given, at the full presentation of the Spotlight data, due to take place today at 1:30pm Pacific time. Thus, since the comparator in Spotlight was chemo alone, the results raise a second unanswered question: how might these patients have performed if given Bristol Myers Squibb’s Opdivo, which can already be used as a chemo combo in Her2-negative gastric/GEJ adenocarcinoma? Tumours of Spotlight patients also had to have adenocarcinoma histology, as well as being negative for Her2. ![]() Spotlight, which Astellas had toplined as positive last November, enrolled only those patients whose tumours tested positive for at least moderate expression of this biomarker. On the face of it zolbetuximab looks approvable, but the data raise several questions, most notably about the need for mandatory Claudin18.2 testing.Ĭlaudin18.2 is a protein said to be expressed in normal gastric mucosa cells and retained in metastatic gastric/GEJ tumour cells, but testing for its presence is not currently standard practice in these cancers. The results, from the Spotlight chemo combo study in front-line gastric/gastroesophageal junction (GEJ) cancer, have just been unveiled in a late-breaking abstract at the Asco Gastrointestinal Cancers symposium. Now here come positive survival data in the first setting in which the most advanced anti-Claudin18.2 antibody, Astellas’s zolbetuximab, might be approved. ![]() Last year saw Claudin18.2 emerge as a sought-after novel oncology target.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |