In Ph2, ARQL tested/analyzed PFS but did not get OS results. Then, Marquee Ph3 NSCLC trial was designed around OS as the primary endpoint. The trial has failed to meet it objectives. It was a major trial design crew-up.
The Ph2 results were great using Tiva in a capsule form. Then, ARQL started HCC Ph3 trial with Tiva in a tablet form assuming that Tiva efficacy and side-effects are the same in two forms. Now, ARQL/Daiichi have discovered that Tiva efficacy and side-effects are not the same in capsule and tablet forms. Tiva in tablet form has much more side-effect as it was learned from both Ph3 Marquee and ongoing HCC trials.
My understanding that there will be very few new Marquee data presented at WCLC..
Daiichi USA has a new management and, since they are paying for Tiva trails, there will not be many if any news before japanese Attention trial is finished in early next year. In other word, this trial will succeed if there are many Asian met-high pts.
Just compare Erbitux and Tivantinib.
Merck KGaA (MRK) said its cancer drug Erbitux extended the lives of patients with a form of advanced colon cancer more than seven months longer than those taking Roche Holding AG (ROG)’s Avastin.
In a trial among 342 patients with advanced colon cancer lacking certain genetic mutations, those receiving Erbitux had a median survival of 33.1 months, compared with 25.6 months for those treated with Avastin, according to data to be presented today at a cancer conference in Amsterdam. Both drugs were combined with chemotherapy.
The findings suggest a role for Erbitux in a sub-group of patients with so-called RAS wild-type tumors, after Merck said in June that the study missed its main goal of shrinking tumors more than Avastin.
Roche Avastin was a King in ITT mCRC but, going to biomarkers-defined sub-population analysis, Erbitux has proven to be far superior to Avastin to a substantial portion of mCRC pts. First, it were KRAS-w mCRC pts who benefited from Erbitux and now came RAS-w pts greatly benefiting using Erbitux.
"Additional data on other molecular subgroups enrolled in MARQUEE are planned for presentation at an upcoming peer-reviewed forum." [WCLC 13, Oct.28]
I was somewhat disappointed in Marquee results even they were good. However, reviewing both Met-High and -Low PFS and OS results, it is obvious that there are additional NSCLC subgroups who will greatly benefit using Tiva. This is possibly a reason ARQL takes its time to identify these high-response pts.
Consequently, I see the game in Met-inhibitors is not over yet. To the contrary, it just started with ARQL having a potentially huge database to benefit from.
This could be interesting. Hopefully, in some sizable subgroups, seeing HR
"Additional data on other molecular subgroups enrolled in MARQUEE are planned for presentation at an upcoming peer-reviewed forum." [WCLC 13, Oct.28] This could be interesting.
The Marquee results for Met-High group is very positive: HR=0.7 and p=0.03 (the results are stat-significant).
In other word, OS was significantly improved and this improvement was stat-significant. The same goes for PFS and RR. If Marquee was ONLY for MET-High pts, Tiva would be easily approved by FDA.
It is of interest that Tiva also benefited Met-Low pts but OS improvement was very small but PDS and RR were very good. Remember that Roche's MetMab is highly detrimental to Met-Low pts.
KRAS-m pts did not see any benefits in ITT general NSCLC population.
However, it is correct, ARQL/Daiichi did not bother to issue a press-release with these positive information. There are many questions ARQL will be forced to answer.
This what you have having a shjty management and shjty partner,
Looks like we are close to a finish line. Either BPH or PC positive results will be highly beneficial to the stock price driving the company MC to well over $1B driving the stock price well over $30. Presently, it is $225M. But, the results must be positive, This is the kicker!
No doubts that some know the results and trade using the knowledge. Present financial markets are fixed. Get used to it. Nobody prosecutes big housed since they own the government and the Congress.
Now, it is very interesting that Oct. 2.5 calls have no premium like nobody expects anything from ARQL ESMO data or it is done deliberately to crew retail investors, IMO, if HR .75 then Tiva and ARQL have no future. Forget about ARQL cash: it will disappear in no time.