This is going to be a thread of our #MCBS session starting in a couple of minutes at #ESMO22. Follow along for a LIVE tweet-summary of our session! @myESMO @ChernyNathan @VriesElisabeth 1/
First, @ChernyNathan is giving an overview of cancer drugs approved by FDA in last 5 years. For more, read his excellent paper in @NatRevClinOncol published earlier this year. @DianaNrco
IO drugs made up almost half of these drug approvals. #ESMO22
OS benefit a little disappointing because for IO I thought OS data were better than other class of drugs.
That graph for substantial benefit is disappointingly low for targeted drugs. @darioT_ @FroitbergM
Ultimately, one-third of approvals have evidence of making patients live longer.
Approvals based on single arm trials (SATs). I will discuss this in detail in my talk as well.
Prof. Cherny asks if we have delivered on the Moonshot Promise. We need more funding for #cancergroundshot to ensure that the innovative drugs actually reach our patients.
Such a critical point raised by @ChernyNathan . FDA announcements should include critique of trial design, not just repeating the industry announcement. cc @PORTAL_Research
Next speaker is yours truly. Joining virtually.
Surprise: OS is not the gold-standard endpoint if it is a single arm trial.
OK, SATs are being used for approval, but they are only conditional approvals, right? Unfortunately, no.
Why some drugs get regular approval and some get accelerated approval based on similar response rates? I don't know!
Similar drugs, similar results, some RA but some AA. What gives?
Why are we concerned?
Are RR from our newer drugs better than what we already had from existing drugs?
Quoting @sarojniraula et al's study showing RCTs were possible for >80% of the cases where SATs were used for approvals.
What ORR is a good ORR?
What is a rare cancer? Can we call lung cancer rare?
What is an unmet medical need?
Here is my 2c on the way forward.
Next speaker is Dr. Branco to discuss on benefits from immunotherapy drugs based on MCBS scores.
Benefit of IO across tumor types based on MCBS. @LuisCB_MedPharm
These patients are systematically excluded from IO trials.
Summary of IO approvals.
What explains the differences?
Crossover rates are disappointingly low!
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