Endocyte, Inc. (ECYT) announced an encouraging interim update on overall survival (OS) of patients in a phase IIb study (TARGET) evaluating vintafolide (a small molecule drug conjugate, or SMDC) in combination with Taxotere for the treatment of folate receptor (FR) positive recurrent non-small cell lung cancer (NSCLC). The company is evaluating vintafolide as a second line treatment for patients suffering from NSCLC who have failed one prior line of therapy.
We remind investors that the TARGET trial initially had three arms − vintafolide monotherapy, combination of vintafolide and Taxotere and Taxotere monotherapy. However, based on the recommendation of the independent Data Safety Monitoring Board (DSMB) to continue the vintafolide plus Taxotere arm and Taxotere alone arm of the study, it was determined that the vintafolide monotherapy arm was not likely to show greater benefit in terms of progression free survival (PFS) compared to Taxotere alone.
The vintafolide plus Taxotere arm of the study showed that the combination therapy led to a 30% reduction in the risk of death and a 27% reduction in risk of worsening of disease or death in comparison to Taxotere monotherapy in a pre-defined adenocarcinoma patient subgroup. Risk of disease worsening or death (PFS) was reduced by 25% in the patients who received vintafolide plus Taxotere. The primary endpoint of the study is an improvement in PFS.
Endocyte will present the above data as late-breaker at the European Society for Medical Oncology Congress (ESMO) later in the day.
Meanwhile, Endocyte is planning to advance vintafolide to a phase III study in patients suffering from NSCLC with adenocarcinoma after receiving final OS data from the TARGET study.
We remind investors that Merck & Co. Inc. (MRK) has terminated its collaboration agreement with Endocyte for the development and commercialization of vintafolide, effective Sep 15, 2014. Endocyte is now solely responsible for the TARGET study on vintafolide.
Additionally, Endocyte is evaluating two other SMDCs – EC1169 and EC1456. While EC1169 is being developed for prostate cancer, the company is yet to select the target indication for EC1456.
We believe the interim OS results from the TARGET study are a major positive for Endocyte. Successful development of vintafolide for NSCLC should help the company overcome the setback faced when vintafolide failed in the PROCEED study for platinum-resistant ovarian cancer.
Endocyte carries a Zacks Rank #2 (Buy). Some other well-placed stocks in the pharmaceuticals sector are Endo International plc (ENDP) and Lannett Company, Inc. (LCI). Both carry a Zacks Rank #1 (Strong Buy).
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