This Sunday, September 8, the HARMONI-2 Trial data will be presented at World Lung by Akeso, a China based pharmaceutical company. This will be the big reveal of the $5 Billion bet by U.S. company Summit Therapeutics (and their Billionaire Founder Bob Duggan). In 2022, Summit bet $500 Million in Cash and $5 Billion in total on the bet that ivonescimab would displace Merk's Keytruda and perhaps overturn the entire immunotherapy market for cancer therapeutics. For many in Biotecch, this is the equivalent of taking out the king.
Only way to take on the King of Pembro is to think differently - there are better combos to open up the market.. #ASCO24: With a promising new Keytruda contender, Summit prepares to spar with Merck - https://t.co/khK0yRU1eI
— Thaminda Ramanayake 🇺🇸 🇱🇰 (@thaminda19) June 3, 2024
In exchange for the gargantuan offer, Summit is receiving the rights to develop and commercialize ivonescimab—known as SMT112 stateside—in the U.S., Canada, Europe and Japan. The company says it plans to start treating lung cancer patients in clinical studies by the second quarter of 2023. - from Fierce Biotech
On Sunday, Summit Therapeutics will release highly anticipated data on its lung cancer drug. https://t.co/mncm6QXilc
— STAT (@statnews) September 5, 2024
The HARMONI-2 Bet
HARMONI-2 isn't just any clinical trial. This trial is going head to head versus perhaps the greatest breakthrough product in Cancer Therapy ever, Merk's Keytruda, or pembrolizumab, in 1st Line advanced non-small cell lung cancer. This trial would perhaps deliver a change in the standard of care and new research and development direction for pharmaceutical companies around the world.
Below is a statement from the SUMMIT Therapeutics press release placing an exclamation point on their own success:
#WCLC24 abstract titles released! Don't miss the plenary Sunday September 8th at 8:30am PDT - I am particularly eager to see the ivonescimab vs pembro HARMONi-2 data from Dr. Caicun Zhou, Neocoast-2 from Dr. Tina Cascone, and the 77T vs CM816 analysis from Dr. @FordePatrick! pic.twitter.com/B7RgLpToRN
— Stephen V Liu, MD (@StephenVLiu) August 11, 2024
That is PDL1 VEGF, so much hype , hope it pans out . $SMMT stock price anticipating this data has tripled .. pic.twitter.com/aIAq2GynGv
— Santhosh Ambika (@RenoHemonc) September 2, 2024
The Social Influencer
Summit Therapeutics made a very interesting hire about 9 months prior to their great reveal at #ASCO24. Dr. Jack West from City of Hope Hospital joined the Summit Therapeutics team in October, 2023.
🚨 Big changes afoot!
— H. Jack West, MD, FASCO (@JackWestMD) October 19, 2023
I'm proud to announce that I've joined Summit Therapeutics (@Summitplc) as VP of Clinical Development! I look forward to my colleagues learning more about the company & ivonescimab.
No more commentary from me on new data, but I'll contribute as I can.
Dr. West isn't just any academic researcher. He perhaps pioneered the role of a social influencer in medicine. Dr. West has been a critical voice on clinical trials in Lung Cancer and has never shied away from casting shade on the decisions by large pharma companies. He's been active on Twitter (or X) for over a decade, created his own education platform known as GRACE, and has an active video presence on YouTube.
IMO, #LCSM community should demand re: #ADAURA that w/o mature OS data, @AstraZeneca must show us data on relapse rates in pts who did v. did not have baseline PET/CT, & country of enrollment, as well as data on BL brain MRI v. head CT for CNS relapse rates. You have it. (1/3)
— H. Jack West, MD, FASCO (@JackWestMD) September 30, 2020
I think KEYNOTE-21G was provocative & worthy of further study but premature, insufficient for FDA approval. Over-reach & greed. https://t.co/xpQrN9fygG
— H. Jack West, MD, FASCO (@JackWestMD) January 12, 2017
T.Leal from @WinshipAtEmory presents LUNAR trial adding TTFs to either doce or ICI, showing OS benefit, but OS benefit in pts on doce arm (1/2 of pts) clearly less. Needs to overcome practical challenges. Suspect will have limited (vy little) uptake where IO is SOC in 1L #ASCO23 pic.twitter.com/ZGC8X9tvhg
— H. Jack West, MD, FASCO (@JackWestMD) June 6, 2023
Riddle me this, Batman: why was contribution of phase not a prohibitive issue w/approval of pembro based on the KEYNOTE-671 trial but is now a critical factor for other trials with same design for same setting? 🤯 https://t.co/2uMc5YXWpD pic.twitter.com/u1g7ExTv14
— H. Jack West, MD, FASCO (@JackWestMD) July 24, 2024
Prior to his move to Summit Therapeutics, Dr. West had been a consistent voice in the discussion and criticism of cancer trials and has also been a paid consultant/speaker for various Pharma companies over the years. He has collected nearly $700K in general payments from Pharma since 2017. This is well above both the U.S. mean and the over10X the mean for his specialty.....source openpyaments.gov
So what has Dr. West said about Summit Therapeutics' clinical trials and ivonescimab—known as SMT112?
An exclamation point on HARMONi-A results. Looking forward to discussing with folks in the lung cancer (& broader oncology) community at #ASCO24.#LCSM #OncoAlert https://t.co/ebsKrHJzw3
— H. Jack West, MD, FASCO (@JackWestMD) May 30, 2024
ASCO 2024: @Summitplc's @JackWestMD on the company's PD-1xVEGF bi-specific vs Keytruda news. $SMMT
— BiotechTV (@BiotechTVHQ) June 2, 2024
Full video: https://t.co/JBydaQucb8 pic.twitter.com/pAdSVREsbQ
Keep me honest. I'm happy to see what the data show over time & see if I'm right or wrong. Of course, I now work for Summit Therapeutics; you can view my comments through that lens.
— H. Jack West, MD, FASCO (@JackWestMD) June 2, 2024
If you think I'm overstating/overpromising, I'm game to let future data adjudicate the question.
Dr. West also had an interesting post regarding his most recent clinical position prior to the move to Summit Therapeutics. Is he casting shade on City of Hope oncologists?
It would depend on the individual docs who are there and working with a patient.
— H. Jack West, MD, FASCO (@JackWestMD) June 17, 2024
I would be happy to talk with interested parties about my experience there. https://t.co/VhLqNxx4hd
— H. Jack West, MD, FASCO (@JackWestMD) June 15, 2024
The Billionaire Behind the Bet
Let's see how the detailed HARMONi-2 data at WCLC turn out, but if SMT112 is a winner, then Bob Duggan's massive 500m $ upfront wager on a relatively unkown asset could be one for the history books (also interesting that BioNTech was able to snatch BNT327/PM8002 for only 55m $).
— Nick (@Lawbitrage) September 1, 2024
So who is Bob Duggan? Apparently he is a swashbuckling billionaire. Below is an excerpt from seeking alpha back in April 2023, just a few months before they hired Dr. Jack West.
Summit Therapeutics (NASDAQ:SMMT) is a project of Bob Duggan of Pharmacyclics fame. This is what keeps our hopes in the future of this company alive, even though the company keeps changing so much that it is difficult to keep up.
Ok so, let's get this straight, a company with a failed pipeline for infectious disease agents, bought the rights to a cancer drug from a China based company and now they have the drug that may upend the entire global treatment landscape in cancer therapy. Also, we will find out more about these data on Sunday.WOW!!!
I read "For Blood and Money" by @nathanvardi on the flight home y'day. Bob Duggan, Wayne Rothbaum, Scientology, BTK inhibitors, Pharmacylics, Acerta. Eye candy for any biotech fan. Highly recommend.
— Adam Feuerstein ✡️ (@adamfeuerstein) January 13, 2023
Nathan will be our guest on the Readout LOUD next week. pic.twitter.com/xFFlkE6xkt
Apparently, Bob Duggan is a Billionaire genius and also one of the largest donors in history to the Church of Scientology
The man who gave Scientology $360 million actually answered the phone https://t.co/R6eKKwJARW
— KOL Pulse AI (@KolPulseAI) September 5, 2024
Interestingly, his ex wife was recently in the social media news for a strange situation with another scientology donor in Switzerland
EXCLUSIVE: We describe a bizarre situation that involves #Scientology's richest donor, Trish Duggan, having another church donor jailed in Switzerland as a private accuser. But the jailed man says Trish invested in his company to fuel Scientology donations. What a strange mess.
— Tony Ortega (@TonyOrtega94) June 13, 2024
Trish Duggan also seems to be one of the driving forces behind Donald Trump's campaign according to Politico..
Florida Scientologist becomes huge Trump donor https://t.co/CzxaMHmQ7f via @politico
— KOL Pulse AI (@KolPulseAI) September 5, 2024
FDA's Concerns with Data from China
Akeso, the Chinese pharmaceutical company presenting the HARMONI-2 data may face a tough challenge with the FDA. The FDA has recently rejected two submissions with clinical trial data from China.
U.S. FDA declines to approve two more China-tested drugs
— Paul Triolo (@pstAsiatech) May 3, 2022
This is 2nd time US regulator has declined to approve drug tested mainly in China. In March, it declined to approve Eli Lilly and partner Innovent Biologics lung cancer drug studied only in China. https://t.co/aPOqp0nhp5
Western drugmakers wanted to bring to the U.S. medicines for cancer and other illnesses that had been largely developed in China. But the FDA appears to be tapping the brakes, concerned about the quality of testing. https://t.co/9F26CapIUO via @WSJ
— KOL Pulse AI (@KolPulseAI) September 5, 2024
Rx For Immuno-Oncology Excess? Top US FDA Cancer Officials Take On Development 'Wild West' https://t.co/LIvkTLIkku
— KOL Pulse AI (@KolPulseAI) September 6, 2024
The Key Opinion Leader community are well aware of the FDA's concerns of these data submitted from China. In fact, Richard Pazdur of the FDA outlined these concerns with STATNews
Pharmalittle: FDA's Pazdur explains his views on Chinese drug data; J&J quietly shut down its Covid-19 vaccine plant https://t.co/jN9gG42VRN via @statnews
— KOL Pulse AI (@KolPulseAI) September 5, 2024
Alright! @asco #asco24 abstracts are out. Most plenary + oral are LBAs so not out yet. Let's check a few of the positive trials we have data for in #LCSM
— gilberto lopes (@GlopesMd) May 23, 2024
1. HARMONi-A - ivonescimab, an anti-PD-1/VEGF bispecific antibody, added to chemo vs chemo alone after EGFR TKI shows… pic.twitter.com/Pz0FtR57bt
Here is Pazdur discussing the "data where we don't have confidence" with regards to clinical trial data from China
Would the FDA approve a cancer drug in America based only on data from studies in China? Richard Pazdur, the FDA's top oncologist, answered that question at our #STATatASCO event at #ASCO24. Read more: https://t.co/SlRmJFRXEq pic.twitter.com/nbP39dzXNx
— STAT (@statnews) June 3, 2024
Key Opinion Leader Concerns from #ASCO24
Also, when the HARMONI-A data were presented at #ASCO24, there were some concerns about ivonescimab. Dr. Aggarwal from Penn Medicine mentioned her worry about lack of CNS penetration.
Important data. I do worry about (lack of) CNS penetration
— Charu Aggarwal, MD, MPH, FASCO (@CharuAggarwalMD) May 31, 2024
In the context of other trials combining immunotherapy with VEGF inhibitors, Dr. Patil of UCHealth Anschutz Medical Campus found the HARMONI-A data confusing based on the mechanism of action of ivonescimab.
I honestly find the HARMONI-A data confusing.
— Tejas Patil (@TejasPatilMD) May 25, 2024
➡️ KEYNOTE-789: no benefit w/ post-osi pembro
➡️ ORIENT-31: sintilimab+bev biosimilar improved PFS post-osi, not OS
➡️ ETOP-BOOSTER: no bev benefit w/ 2L osi
But PD1/VEGF bispecific w/ PFS benefit?@EGFRResisters @lcsmchat #asco24 https://t.co/R4rcyt0hYu
Why World Lung?
It's pretty obvious that #ASCO24 got played by Summit Therapeutics. The Summit Therapeutics press release at ASCO regarding HARMONI-2 drove the $SMMT stock price to the moon, without needing to present the data behind the press release. Summit Therapeutics stole the show, and made their investors and senior leadership rich (or more rich) overnight.
As EQRX discovered, they will not be able to use China-only clinical data for US approval and will at least have to repeat the trial in the US. It then begs the question about the reliability of Chinese clinical data and if the result will repeat. $SMMT
— Richard J Law 🚜--🇺🇦 🍉 (@drrichjlaw) May 31, 2024
So what will World Lung bring? Pazdur from the FDA has made it very clear that the FDA has a concern with their lack of confidence in the data from the clinical trial sites in China. Have the leadership at IASLC done anything to alleviate these concerns? If not, is it irresponsible for the World Lung Conference leaders to place HARMONI-2 as a plenary at this meeting? Is World Lung now the Robinhooder's choice for clinical trial data rollouts?
I guess you can't blame the IASLC leadership if they did not visit China to generate confidence in the HARMONI-2 clinical trial sites?. Just look at what happened to those AstraZeneca employees this week!!
China Detains AstraZeneca Employees Over Alleged Transport of Unapproved Drug—Some recently introduced Western medicines remain unavailable to Chinese patients@raffaelehuang https://t.co/kqrhXZra8nhttps://t.co/kqrhXZra8n
— Jonathan Cheng (@JChengWSJ) September 6, 2024
Keytruda vs ivonescimab
Are you ready for World Lung? Will the Key Opinion Leaders bring their insights on these data?