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Take my word MARQUEE results for c-MET+ 2nd-line patients will be very good. Why?
- Pucci mentioned that PFS was very good but mOS was very poor
- Pucci also said that 200+ patients were still alive and getting Tiva. Remember that the previous Tiva Ph2 in NSCLC and historical NSCLC indicate that these 2nd-line NSCLC patients have PFS `2 months and OS~7 months. This means that 40% of MARQUEE patients who got Tiva are alive & well and their disease did not progress after more than 8+ months after getting the Tiva treatment. Again, most of these patients supposed to be dead by now but they are still alive without disease progression. So, these patients will be alive for ~12 months. This is what the best NSCLC drugs can do for the 1st-line patients.
Tiva works in NSCLC for c-MET+ patients. MARQUEE trial was poorly designed targeting the wrong patient population. However, there are plenty of c-MET+ patients to show and to prove the Tiva efficacy in this NSCLC subgroup.
Pharma..thank you for the post and continued insight. I have been a long time investor in ARQL and disappointed by the news obviously, but I tend to agree with your analysis as far as the drug needing to be targeted at c-MET+ population. The failure of the MARQUEE trial is not inconsistent with this requirement and therefore the investment continues to make sense to me. Even though that means we are working with a smaller population and therefore a smaller market potential, I would think that success in 1 indication for a c-Met expressed population would get us back to the $6-10 range. If you believe that, this would be a perfect opportunity to lower the cost basis. I'm not one to throw good money after bad, but someone was thinking the same the other day when we were up 20% off the bottom.
I am a scientist and a good one. I know how to analyze data.
Let us review the facts/results:
- MARQUEE is a 1,000 pts trial. 500 pts got placebo and 500 pts got Tiva.
- If there was 50/50 c-MET+ and c-MET- patients split then only ~ 250 c-MET+ pts got Tiva
- As of 10.02.12, 200 pts were still getting Tiva. This is 40% of all ITT pts and ~75% of c-MET+ pts
- c-MET- pts don't respond to Tiva and live ~6-8 months
- c-MET+ placebo pts live only ~3.8 months (Roche MetMab Ph2 data)
- MARQUEE has at least 60%+ of its c-MET+ pts who are still alive after 7-8 months without disease progression
- NSCLC market is huge. It is larger than prostate, CRC, and breast cancer markets combined.
If Pucci is ready to leave NSCLC where Tiva works for 50% of all pts then he is an incompetent idiot! Then ARQL must be sold to a company capable of running clinical trials and helping to so many NSCLC pts.
Accordingly to the government clinical trials website, there are almost 30 trials of Tiva by ARQL and major medical centers and NCI. This shows that medical research community gives much more credit to Tiva than WallStreet criminals.
If one look at Roche NSCLC Ph2, they used almost 4-5 ways to measure c-MET value. This is why Roche Ph3 is moving slowly. Just way to measure c-MET is still an open issue.
Two more things. MARQUEE pts who are still well and getting Tiva are the people who hold the key to c-MET inhibitors enigma since they have something (some biomarker) telling who are and who are not benefiting from Tiva.
All Tiva trials will be going forward will that c-MET pts will be tested for c-MET.
About Roche. They tested MetMab on very few NSCLC patients. So, they don't know for sure that c-MET+ is the right indicator. Otherwise, they could enroll and complete their Ph3 trial in less than 2 years.
major strategic error. in fairness, that's with benefit of hindsight. Now metmab has inside track for nsclc and we go from being maybe 18 months ahead to basically being sidelined for this indication or best case 18 months behind. Now we just have to wait with fingers crossed for CRC.
You are incorrect.
You don't know that any drug is working before it has been proven in clinical trial. Otherwise, there would not be any need for clinical trials and there would not be so many failures in Ph3 by the best and brightest. There is no any prove that Metmab will work. Roche tested less than 60 patients. Many patients left the trial due to toxicity and at their doctor advice. MetMab was absolutely terrible in c-MET- patients.
This is the pharmaceutical business. This is why there are so many similar but different statins, antibiotics, diabetics, etc., drugs.
my point is, again with benefit of hindsight, would have been better to focus on cmet+ rather than broader population...I recognize pointless to speculate but no denying now marquee was poorly designed. Roche is focusing on cmet high pop becauase basically they had no choice...neg- effect on broader population ...obviously no guarantee they will succeed either with cmet+. mention of amgen interesting...they're now testing a cmet drug in gastric.
agreed re NCI trials.also sorafenib+tiva for melanoma ph1 looked good, with small numbers admittedly. Going back to your cmet+/NSCLC comments: do you know if the ph2 kras mutant trial has been stratified by cmet status? If so, maybe that's another strong avenue back to ph3 in NSCLC, this time focused on kras mutant and cmet+...is that a stretch at this point?