Seeing Poziotinib’s sales potential through Tagrisso’s eyes. Tagrisso (osimertinib) from AstraZeneca is a third generation, irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations. It was just approved in the US for patients with metastatic epidermal growth factor receptor (EGFR); it’s approved in China and the EU too. T790M mutation-positive non-small cell lung cancer (NSCLC) occurs in 10-15% of NSCLC patients. This is info I got from AZs March 31st PR. And according to Thomson Reuters, consensus forecasts is for $2.5 billion by 2022.
Now, let’s look at Poziotinib that started dosing patients in a P2 trial this month as per the recent PR. It is being tested in patients with EGFR exon 20 insertion mutations. Their PR from Nov indicated that 10% of NSCLC patients may have this condition. From one of SPPIs recent CCs, I remember hearing 4 – 7% may have this condition. Let’s say ~7.5% have this condition and in comparing it to Tagrisso (10 -15%), let’s say it’s one-half of Tagrisso’s targeted population. A good rule of thumb is to divide the world in 3 equal parts; the USA, EU and Rest of World (ROW) which includes China, Japan etc. So assuming Poziotinib shows effectiveness in this P2 trial data with end of this year readout and it successfully undergoes a registrational P3 trial then what is the sales potential of poziotinib? At ½ of Tagrisso’s patient population that puts sales at ½ of 2.5B or $1.25B for the whole world market. Let’s assume that it will be approved only in the US so 1/3 of 1.25B is $417M. Add the EU to the mix and that makes $834M. That’s not including ROW (I assume they’ll get a partner for that and for the EU for that matter). And that doesn’t include the different indication of metastatic breast cancer where P2 trials are ongoing.
This discussion may be slightly premature since we don’t have any concrete data yet so why get excited now? Well, we have pretty good pre-clinical data showing poziotinib superior to some other TKI molecules as presented by MD Anderson at the 17th IASLC World Conference on Lung Cancer on Dec 7, 2016, we have a patient with EGFR exon 20 insertion mutation given poziotinib showing encouraging results, we have MD Anderson which is one of the more prestigious cancer centers in the country very much involved, and we have the P2 trial starting earlier than expected (clin trials had it starting in April but it started on March 17th). Sure it’s not the same as trial results that’s expected at the end of the year but not too late to start thinking of the possibilities of what it will do for Spectrum, and for pts, if the trial is successful. Ariad being bought out by Takeda for 5.2B comes to mind. Ariad in the 3rd Qtr had like 34M in sales, and part of that was from major price increases that got them in hot water w the US congress. The 18th IASLC World Conference on Lung Cancer will be in Dec. That’s like, kind of, perfect timing if the stars are aligned right for the MD Anderson P2 trial readout. Spectrum has had bad karma the last couple of years w Fusilev, it’s time that changes and this may be what changes it. Hearing that the Rolontis P3 trial has finished recruiting patients wouldn’t hurt either since we would know results will come quickly afterwards w NDA submittal.
