Bishal Gyawali Profile picture
Sep 9 27 tweets 10 min read
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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More from @oncology_bg

Feb 1
Just out in @TheLancetOncol ! Much has been discussed about the FDA accelerated approval system; but what are its consequences for global oncology? This paper with @SuyogCancer and @SirohiBhawna ties my two passions: cancer policy and global oncology. thelancet.com/journals/lanon…
Accelerated approval process doesn’t affect cancer care in U.S alone. It has global consequences. Patients in LMICs continue to pay -from their pocket- for cancer drugs with low quality of evidence simply because it’s approved by the FDA. thelancet.com/journals/lanon…
But the biggest shock is this- when a drug receives AA by the FDA, it gets promoted to oncologist across the world as a FDA approved drug. But when the confirmatory trial fails and approval is withdrawn, it is NOT withdrawn from the global market. thelancet.com/journals/lanon…
Read 6 tweets
Jan 18
Cancer screening is a double edge sword. Better technology simply could mean we are able to pick up smaller tumors that may not have needed treatment. Important data from Taiwan on lung cancer screening. jamanetwork.com/journals/jamai…
What does this picture say?
This is classic picture of overdiagnosis. Increase in incidence, increase in survival but stable mortality.
Read 5 tweets
May 26, 2021
I’m officially starting my faculty career in academic oncology as an Associate Professor @queensoncology @QueensUHealth from June 1st, 2021. I’m super excited about it, and very thankful to everyone who has had a role in making this happen. This is a twitter thread of gratitude.
First of all, I’m extremely thankful to my mentor Chris Booth. Honestly, Chris is the reason I moved to Queen’s. He has not only supported me in my career but has also been a great friend and advisor. I feel lucky to be working with him.
My immense gratitude to my mentor and department head @scottrberry. Scott has been incredibly supportive and helpful, and left no stones unturned to make this happen. He was never busy to not have time to listen to me. He’s a boss you’d want to work hard for.
Read 9 tweets
Apr 11, 2021
It was my pleasure sharing some thoughts on communication skills in oncology with the participants of @ecancer #Kolkata21 meeting today morning. The video is already available to watch for those interested: ecancer.org/en/video/9670-…
With special thanks to @ChernyNathan @scottrberry and @ramsedhom for providing me advice/thoughts/slides to make this talk possible. I myself learned a lot in this process.
Many thanks to @HealthCommunic2 for organizing the event. Missed meeting all dear friends and colleagues in person, hopefully next year we can.
Read 4 tweets
Mar 31, 2021
Published just now in @ASCO_pubs JCO Global Oncology. The FIRST report of a population-based cancer registry from Nepal. It felt very meaningful to contribute to this #cancergroundshot project. ascopubs.org/doi/full/10.12… #globaloncology Image
For the first time, we now have official data on the commonest cancers in Kathmandu by incidence and mortality in different subgroups of population. ascopubs.org/doi/full/10.12… Image
The population-based cancer registry has only just started in Nepal, and there are plenty of room for improvement. But I hope this provides the foundation for stronger work in the future. ascopubs.org/doi/full/10.12… Image
Read 4 tweets
Mar 11, 2021
Very happy to see this announcement today from @FDAOncology . Early approval based on surrogate and appropriate action upon failure to confirm clinical benefit in confirmatory trial is the mandate of accelerated approval. fda.gov/news-events/fd…
Several of our works @PORTAL_Research have previously highlighted that this follow-through has not been happening. Failure to act when drugs fail to improve clinical benefit in confirmatory trials breaks the social compromise of AA. I will share 2 imp papers in this regard.
First, in this @JAMAInternalMed paper we published last year, we show that confirmatory trials do not confirm clinical benefit using survival endpoints and even when confirmatory trials fail, no actions are usually taken. jamanetwork.com/journals/jamai… @akesselheim
Read 5 tweets

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