Oncomed Pharmaceuticals Inc (NASDAQ:OMED) put out its second-quarter earnings earlier this month, and alongside the numbers, gave us an update as to the progress of its development pipeline. Specifically, we got an estimated data dump date for its lead development candidates, Tarextumab and Demcizumab.
Both of these drugs are in phase 2 trials right now, and the importance of these trials is rooted in two potential opt-in agreements that would see Oncomed partner with GlaxoSmithKline plc (ADR) (NYSE:GSK) on Tarextumab and Celgene Corporation (NASDAQ:CELG) on Demcizumab. In turn, these combinations would kick off two large-scale pivotal phase 3s worth up to $172 million in opt-in related milestone payments to the company. Ahead of the data, therefore, here is a look at what we are watching out for when the numbers hit.
First up, Tarextumab. This one is a first-line small cell lung cancer target indication, and it goes after what’s called the neurogenic locus notch homolog protein 2 receptor, or for short, notch 2 receptor. Notch 2 is a protein that plays a key role in cell replication and proliferation, and through inhibition of the receptor associated with the protein, Oncomed aims to halt progression in the cancer in question.
The drug is currently under investigation as part of two distinct phase 2 trials. The first, a phase 1/2 looking at a combination of Tarextumab and two already approved anti cancer drugs, nab-paclitaxel and gemcitabine in a target indication of pancreatic cancer (note: not the same trial as the Demcizumab study mentioned above). The second, again a phase 1B/2, and the one due to report late 2016 early 2017, is investigating the drug in combination with an anti cancer drug called Etoposide and platinum therapy.
There are two primary endpoints associated with this second trial. One is dose limiting toxicity, which we are not that concerned about as far as what impact it will have on markets is concerned. The second, and our primary focus, is progression free survival. The trial is placebo-controlled, so what we’re looking for here is pretty simple – a statistically significant improvement in progression free survival between the placebo arm and the active arm. An important secondary endpoint is also overall survival. From an FDA perspective, overall survival is probably what will play into any potential approval most heavily, and so again we are watching this one for a statistically significant improvement in the active over the placebo arm.
Moving on to Demcizumab, this one is a pancreatic cancer trial and is designed to compare the efficacy of a combination of two already approved cancer drugs, gemcitabine and Abraxane, in combination with placebo, and the same two drugs in combination with Oncomed’s Demcizumab. The specific type of pancreatic cancer that the trial is investigating, metastatic pancreatic ductal adenocarcinoma, is the most common form of pancreatic cancer, but it’s also very aggressive, and has a pretty poor prognosis on diagnosis. Why is this important? Well, because Oncomed Pharmaceuticals Inc (NASDAQ:OMED) shouldn’t have to demonstrate too much of an improvement between the placebo arm and the active arm in order to justify moving into a pivotal phase 3.
The endpoints on this one are slightly different. There is no maximum tolerable dose primary; instead just an investigator assessed, median progression free survival from randomization. Similar to the above, however, we’re looking for an improvement over placebo as an endpoint hit. The secondary endpoint derives from an industry-standard measurement for evaluating the response to treatment of solid tumors called Response Evaluation Criteria in Solid Tumors (RECIST). Basically, the measurement takes a number of inputs to calculate tumor burden, and based on this tumor burden, assigns a score from baseline for the patient in question. It then uses the score (generally expressed as percentage) to assign a rating – complete response, partial response, progressive disease or stable disease. The higher the decrease in burden, the better the evaluated response, the better the performance of the drug.
So there we go. Two very important trials sets to report across the next few quarters, which will likely dictate market sentiments towards Oncomed Pharmaceuticals Inc (NASDAQ:OMED) for the coming few years. If both trials come out as indicative of efficacy, expect a rapid upside revaluation in the company’s market capitalization early 2017.
Note: This article is written by Mark Collins and was originally published at Market Exclusive.