As a biotech investor for many years, mainly in oncology. I have to say if Investors agree with this article, they are foolish and don't know the data or how oncology works. I have studied the oncology biotech industry for years. Furthermore, I had a family member recently passed away after battling lung cancer for a long time, so I know the drill first hand. I wish Rociletinib was available to him.
Rociletinib would easily have achieved 60% response rates if 80% of their clinical trial demographics were Asian. Rociletinib will actually do better in the real world because the study demographics were reflective of what most oncologists see with their patient population. Furthermore, you don't see rash and diarrhea with Rociletinib which gives patients who are EGFR positive a piece of mind. Patients and providers are tired of the rash with these class of EGFR TKI drugs! Also, Roci was effective in the EGFR negative patients! Are you kidding? If I am correct, only Tarceva had only a little efficacy in EGFR negative patients and look at its success. Tagrisso is non effective in EGFR negative patients and they stacked the deck with the EGFR positive patients by enrolling mostly Asian patients in their clinical trials. They are a much larger company with much more $$ and know how to play the game to achieve approval. Clovis is learning. Look what happened when Afatinib was approved. They stacked the deck with Asian patients in their clinical trials and that launch was a failure! Efficacy in the real world for Afatinib did not equate consistently to what the clinical trial outcome achieved. Also, more side effects! Therefore, Tarceva far remained the winner in this category. This is the same between Rocileitinib and Tagrisso. The FDA would be foolish not to approve this drug where there is only 1 other drug in its class. In reality, it is the ONLY drug in it's class because it has efficacy in the EGFR negative patients. Which Tagrisso does not. It is unbelievable that breast cancer drugs get approved on a 2-3% better response rate! I would hope the FDA is much smarter. If not, we are in trouble.
Like I said, there is only 1 drug in this setting for patients who have progressed on initial EGFR TKI therapy that have the T790M. Why would a patient go back to IV chemo after Tagrisso therapy that late and not take this drug which has a better side effect profile than Tagrisso? Or, would they give up and go right to hospice? Crazy. Those patients would have another solid option now to prolong life at a good quality.
Even if the response rates were in the 30% range, that is still awesome data considering the patient demographics in the clinical trials were real world. Which = more robust data. Also, All other therapies previously used in this setting related to about 10% response rates and lower with bad side effects. Terrible data at a cost for years. Or, the patient did not have a performance status to go on IV chemo again and went to hospice. There is a definite need for this drug. Rociletinib could eventually be used before Tagrisso and overtake Tarceva in the future. If approved, I guarantee eventually it will replace Tarceva because it is effective in all comers with no rash or diarrhea! As we know, only about 10-15% of the lung cancer patients are EGFR positive. Wouldn't it be nice to give a drug that is effective in the EGFR negative patients as well at that setting? That is in incredible! So, you would have the patients who are EGFR positive with the T790M covered. AS well as the EGFR negative patients. That is a win-win that Tagrisso can't offer.
Moreover, you can use Rociletinib in combo therapy (which is starting to be studied in collaboration)/ The FDA halted all combo trials with Tagrisso. I wonder why? I am shocked the FDA did not research into this issue more. Maybe because AZ has billions of $$$? Look at renal cell cancer. There are about 10 me2 drugs in that setting. Most of the drugs are the same with the same efficacy. Again, there is only 1 drug in this setting and it is treating one of the top 3 most difficult tumor type cancers to treat. Lung!
Like I said, it would be foolish for the FDA not to approve this drug. Great time to buy Clovis! If the FDA does not see this, we are in trouble. AZ probably is behind this article. I am tired of big pharma games.
P.S. I am just comparing Tagrisso. There is a need for that drug too as with all cancers there is a need. I am just comparing as a long term investor.