3 Things In Biotech You Should Learn Today: April 11, 2017

by: Zach Hartman


Roche's lung cancer TKI smashes Xalkori in first-line trial.

Pancreatic cancer claims another victim: OncoMed Pharmaceuticals.

Cutaneous T cell lymphoma poised to take another hit, this time from Medivir AB.

Hello readers! Welcome back to another installment of "3 Things You Should Learn Today in Biotech," a digest where we cover recent developments in the biotech world that can impact on both short- and long-term outlooks of companies. Today we're dealing with some smashing events — some good, some not so good.

Roche's (OTCQX:RHHBF, OTCQX:RHHBY) lung cancer TKI smashes Xalkori in first-line trial

Competition in the space of so-called ALK-positive lung cancer for several years now, ever since the first approval of Xalkori in 2013. This marked a dramatic improvement in the standard of care for patients who had this specific form of lung cancer. And ever since, other companies have worked to develop innovative new forms of ALK inhibitors.

One of the two big upstarts in ALK-positive lung cancer is alectinib, manufactured by Roche, which has already been approved for treatment after patients fail Xalkori. Sights have since turned to studies involving earlier treatment, with the holy grail of first-line therapy in sight. Clinical trials like J-ALEX showed last year that alectinib compared favorably to Xalkori in first-line treatment with an improvement in progression-free survival. However, J-ALEX recruited only Japanese patients, and the worldwide ALEX study has been hotly anticipated ever since.

Now, Roche has provided a peek into the results of ALEX. Alectinib is confirmed to improve progression-free survival over Xalkori, with a lower frequency of adverse events.

Looking forward: I've seen this hailed as one of the big pharmaceutical victories of 2017. Personally, I see it as a major stepping stone toward a new standard of care for ALK-positive lung cancer. You don't usually see such a striking improvement in efficacy without a tradeoff of newer, worse toxicity. That wasn't the case here. Moreover, alectinib gets into the brain more easily, providing better control over metastasis in the central nervous system than Xalkori. The ALEX study also will probably give alectinib a nudge over competitor ceritinib, which has been studied in front-line in comparison with chemotherapy only.

Pancreatic cancer claims another victim: OncoMed Pharmaceuticals (NASDAQ:OMED)

One of the flagship products being developed by OncoMed Pharmaceuticals was demcizumab, a monoclonal antibody that was thought would help eliminate cancer stem cells and kill the roots of the tumor.

Today, OMED announced that its phase 2 trial (YOSEMITE) in pancreatic cancer missed its primary endpoint of improving progression-free survival. Demcizumab had been combined with Abraxane plus gemcitabine, one of a few chemotherapy options in metastatic pancreatic cancer.

Unfortunately, neither progression-free nor overall survival were improved over chemotherapy alone. OMED announced that it would look for subgroups of patients that might benefit, but that it would also be discontinuing further recruitment for demcizumab clinical trials. These findings, in conjunction with an announcement that Bayer has terminated its option to invest in its other Wnt pathway inhibitors, led to a precipitous decline in stock price and overall outlook for OMED.

Looking forward: Pancreatic cancer claims another victim. To look at the development of therapies for this tumor type is to see a grim battlefield with very few successes, which is why results like NAPOLI are hailed as breakthroughs. But for OMED, where there's blood in the streets, the savvy investor may see opportunity. Though Bayer declined to exercise its option, that does not mean that the company's entire pipeline is dead in the water. They maintain collaboration with Celgene, and they have a number of other bullets in the chamber, though not that far in clinical development. I'd say put OMED on your watchlist.

Cutaneous T cell lymphoma poised to take another hit, this time from Medivir AB (OTC:MVRBY)

If you caught yesterday's edition of the digest, you saw my thoughts on Kyowa's new trial for an experimental therapy in cutaneous T cell lymphoma, which has historically been pretty tough to handle.

As it turns out, the hits might just keep coming from researchers. Now, Swedish pharma Medivir AB has announced promising results from a phase 2 study of remetinostat, a topical version of a drug in the class of histone deacetylase (HDAC) inhibitors. The highest dose of this agent yielded a response rate of 40%, with no evidence of body-wide toxic effects.

Based on these promising preliminary data, Medivir intends to move forward with larger-scale trials in the future. A formal presentation of the results will come in the second half of 2017, perhaps at ESMO or ASH.

Looking forward: Cutaneous lymphoma does not have an excess of treatment options in the standard armamentarium at this time. Thus, every new entry that shows promise is going to be looked at very seriously with regulators. Considering Medivir has taken a beating since 2016 (down to near $70 per share from its 52-week high of $102), every bit of good news is needed to stave off further bleeding. Considering HDAC inhibitors have already gained a foothold for management of relapsed cutaneous T cell lymphoma, Medivir might be able to make a mark with its topical formulation, as this presumably provides a safer alternative to systemic options like romidepsin. Patients can theoretically continue using remetinostat for as long as it keeps working, without much worry of treatment-limiting toxicity.


Thank you for tuning in. 2017 has so far proven to be a big culminating year for a number of reasons, and the alectinib study is one of the hallmark achievements in pharma so far. If you'd like to continue reading this digest of new biotech findings, please consider following me on Seeking Alpha.

Also, if you happened to miss some of the material events from yesterday, please consider checking out Monday's edition of the digest, where I covered CAR-T therapy, along with a potential up-and-comer in the space of hormone therapy for uterine fibroids.

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