RE:RE:RE:RE:RE:RE:ASCO relevanceZynyz is yet another PD-L1 inhibitor. Don't forget that the company received a CRL for the same indication 2y ago and this was not a novel application for a previously unapproved line of drug. Even saying that, a very significant surprise.
Tukysa is yet another TKI that provides the option for dual therapy in those rare cases of RAS- Her2+ metastatic colon cancer.
Both of these approved for meds with a long history of clinical safety. These are "me-too" drugs where there are established safety and efficacy records for the treatment class. Both of these treatments established responses and depth of effect unexpected by historical treatment. Duration of effect was impressive for both. These approvals provide an option for treatment in quite rare clinical situations where large, randomized studies are just not possible. This is an important development for a small number of patients
Approving Pela is a different kettle of fish. In North America, about 50,000 women will be diagnosed with metastatic breast cancer per year; about 150,000 will find out they have metastatic disease after a prior diagnosis. This is the immediate, incident addressable population that the FDA has to consider. Pela has developed a large cohort of safety data with more than 1000 patients treated with IV therapy but the safety package will be intensely scrutinized. ONCY's clinical treatment studies have been going on for a very long time, for many indications.....and the company has not demonstrated enough clinical effect to establish approvable efficacy to treat any cancer. The nature of these difficulties will be examined in detail.
The company may have finally found a successful indication but the FDA will not approve a novel agent without a fight! The impact of such an approval would produce a massive shift in the treatment of mBC for the Oncology community. Such an approval has to be more than air-tight before the breast cancer treatment community will accept a tidal wave change. The FDA would also be aware that the indication for Pela could easily creep into first-line (based on AWARE-1); a situation that could triple the addressable population. The first approval has very big implications for the scope of breast cancer treatment but also paves the road for approval in other indications (millions of patients).
It is one thing to offer compassionate treatment to hundreds of patients with a biological rationale for targeted therapy. It is entirely another ball of wax to approve a treatment that is a monster paradigm shift affecting every breast Oncologist in the world. Another reason why ONCY will negotiate a very powerful partner......to get this over the line with the regulatory bodies.
I think that the combination of results will look good and I think that there will be discussions with the FDA about the road forward. I would be very happy to see AA contingent on future clinical monitoring of a Ph III or something like that. I really don't think that will happen but I do think that the company now has the clinical data that will induce a significant partnership and, for me, that is a massive win.
As frustrating as it is, they have to put one foot in front of the other and do things correctly.
cheers, Geneman