Biotech Values

[biomaven0]

The Chugai drug was in Xalkori-naive patients, so it's hard to compare. Also, historically, Japanese early-stage NSCLC trials seem to do unusually well for some reason.

If you look at the details of the '113 responses, there was only a single patient that showed no tumor shrinkage (stable disease only) out of 18 NSCLC patients enrolled as 1st-line (naive) or 2nd-line (post-Xalkori).

The reported results look somewhat worse than that because one patient had a 29% response (not meeting the 30% cut-off for PR), and a second patient was considered as PD because of an unrelated tumor.

The single patient with both progressive disease and no tumor shrinkage was post both Xalkori and LDK.

So post-Xalkori, we have 16 NSCLC patients:

12 responded (2 with 100% shrinkage)
1 responded but classed as PD because of melanoma
1 stable disease with 29% shrinkage
1 stable disease (no shrinkage)
1 PD with 50% shrinkage

Naive we have 2 patients:

1 CR
1 stable (29% shrinkage)

3rd-line 2 patients:

1 stable (10% shrinkage)
1 PD

For a Phase I trial where presumably some patients were dosed suboptimally, that's an outstanding set of results.

The other issue with the Chugai drug is that there are some mutations (V1180L and I1171N, and perhaps G1202R) it will very likely not be able to handle.

I do agree it is still early in the game, but my prediction is that '113 will indeed eventually prove best in class in ALK+. Better efficacy than LDK for brain mets and better reported patient tolerability as well. ASP3026 doesn't have great potency, and CH5424802 misses some key mutations.

Peter