TGTX from Roth Capital
TG announced updated monotherapy data at ASCO this weekend for both TG-1101 and TGR-1202 in advanced hematological malignancies. Discussing both data sets with KOLs, an underlying theme is not only the strong efficacy results, but also the level of safety shown to date, which should make combination therapy an easy next move. TG-1101 data in 30 patients showed both strong response rates and safety in multiple lymphoma types. Recall that patients in this study saw 2 or more prior Rituxan regimens and were relapsed/refractory (43% of patients were refractory to Rituxan). Across the different lymphoma types there was 30% PR and 13% CRs. The CLL patient group showed greater efficacy, showing 67% PR rate. In the TGR-1202 study, once per day dosing as well as favorable safety profile bolstered strong efficacy data as well. Marked efficacy was seen in relapsed/refractory CLL patients showing a 78% nodal response at doses 800 mg or higher (median time on study 6+ months).
Impact
We are impressed with the data and we received the same question from investors; "Did you expect the data to be this good?". The KOLs running the studies are strongly behind these clinical data, especially the safety profiles, which make the therapies amenable to combination therapy. We believe TG has delivered solid proof of concept data for both drugs. We now look to two key upcoming catalysts. Of particular note, we look forward to seeing the data from the potential "match made in heaven" combination studies; 1) '1101 + Imbruvica in advanced B-cell tumors and 2) '1101 + '1202 in advanced B-cell tumor shortly. Second, one or both of these drugs is expected to enter pivotal studies by the end of 2014.
