Halozyme Therapeutics Inc (HALO)

[OncoJock]

Data from IMscin001 have been submitted to health authorities globally.

Agree, this statement is very broad.

Roche, headquartered in Switzerland, operates globally. So I would think this may include health authorities in the USA, Canada, Europe, Japan, the UK, and anywhere else that atezolizumab has won a regulatory approval for one or more indications.

Even though this trial was in lung cancer, the key data relate to pharmacokinetics and bioavailability which shouldn't change according to the tumor type (lung, kidney, skin, etc.). I'm guessing at least some of these regulatory authorities will be satisfied with these trial data from lung cancer and permit them to be extrapolated, or extended, across other indications in other tumor types.

Would you agree? Or do you think these global health regulatory agencies will require Roche, for example, to conduct a new phase 3 trial in renal cell carcinoma (RCC) before awarding an indication for the subQ formulation of atezolizumab to be substituted for the IV formulation in RCC? And then again for melanoma, and again for hepatocellular?

-- OJ