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Monday, June 3, 2019

ASCO Day 4 blog

Exclusive live coverage from day four of the American Society of Clinical Oncology’s annual meeting in Chicago.
• To view all of our coverage from the preeminent cancer event, produced in association with Kantar Health, as well as additional content, visit the Spotlight on ASCO 2019 and the future of oncology
Key highlights for Monday:
  • Seattle Genetics will present details of EV-201, also known as enfortumab vedotin monotherapy in locally advanced metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors.
  • Bayer will present additional data on its larotrectinib in TRK fusion cancers, a precision medicine that works on cancers of any origin in the body that are driven by the mutation driven by tropomyosin receptor kinase (TRK).
  • Another highlight is an oral presentation of the first phase 2 data from the CaboGIST study (trial 1317) from the European Organization for Research and Treatment of Cancer (EORTC), investigating the activity and safety of Ipsen/Exelixis’ cabozantinib in patients with metastatic gastrointestinal stromal tumour after failure of imatinib and sunitinib.


View the live coverage from day four at ASCO 2019 below (the live blog may take a few seconds to load) and we will also have live coverage from day five at ASCO:
More from the cabozantinib presentations
KModyMD@kmody29
 @ExelixisInc @GABOUALFA Present data showing assoc b/w HTN and OFS/OS with Cabozantinib in  pic.twitter.com/tVeWm2hMUf
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Cabozantinib data is being presented this morning, and is certainly making an impact.
UCSF Cancer Center@UCSFCancer
Katie Kelly @UCSF offers “Phase 3 (COSMIC-312) study of cabozantinib in combo w/ atezolizumab vs. sorafenib in patients with advanced hepatocellular carcinoma…” View abstract for poster: http://ow.ly/TB2A50uuO7v 

Phase 3 (COSMIC-312) study of cabozantinib (C) in combination with atezolizumab (A) versus sorafe…

abstracts.asco.org
More from that larotrectinib data presented yesterday.
Sergio Vázquez@SVazqueze
Larotrectinib, a pan-tumor NTRK inhibitor, has an impressive ORR of 94%, 35% CR, and mDoR, PFS, and OS not reached in TRK fusion-positive cancers, with a very good tolerance. The pan-tumor NGS age has arrived. At  pic.twitter.com/al2gByG6ci
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It looks like a few things got moved around in the schedule. There is already some larotrectinib data floating around from yesterday, including this paper with some case studies in patients with brain metastases: https://ascopubs.org/doi/full/10.1200/PO.19.00009

Also this morning was a brief presentation from the FDA’s Richard Pazdur, director of the regulator’s oncology Center of Excellence.
The FDA wants to highlight Project Facilitate, which aims to enable patients to access to investigational oncology drugs.
The Reagan-Udall Foundation has a navigator website providing information sponsors’ policies and listings on ClinicalTrials.gov.
Meanwhile Project Facilitate will provide continuous support to healthcare professionals throughout the EA process.

Finding patients to take part in clinical trials is always a vexing issue for pharma.
Latest results suggests using expanded criteria would enable nearly twice as many lung cancer patients to consider trial participation.
Findings of the study led by Professor Donald Harvey of the Winship Cancer Institute of Emory University, show that broadened trial criteria resulted in trial populations more reflective of the patient population.
ASCO is urging all clinical trial sponsors to adopt wider the wider criteria piloted in the trial and only exclude patients for compelling scientific reasons.
The broadened criteria were: including patients with another primary cancer that does not interfere with safety/efficacy, including patients with treated and/or stable brain metastases and relaxing rules protecting against kidney toxicity.
Results: using traditional exclusion criteria generated a trial with 5,495 non-small cell lung cancer patients. Using expanded criteria almost doubled this, adding 4,851 patients to produce a trial involving 10,346 people.
In the broadened trial 22% were older than 75, compared with 16% using the traditional criteria.
This is important as there is a need to include more older people in cancer trials, said Prof Harvey.

Some promising results from Seattle Genetics/Astellas’ antibody-drug conjugate enfortumab vedotin.
The drug is being tested as monotherapy after previous treatment with platinum chemo and immune checkpoint inhibitors has failed.
Most patients receiving standard chemo require subsequent treatment in this disease.
Second line PD-1 or PD-L1 checkpoint inhibitors yield low response rates and there is no standard therapy for patients after this line of treatment.
Enfortumab vedotin targets Nectin-4, a therapeutic target highly expressed in multiple solid tumours.
Results discussed at ASCO were from one cohort of the EV-201 trial – patients had been treated with platinum chemo and PD-1/PD-L1 checkpoint inhibitor.
Results at this stage show a 44% response rate and a complete response of 12% and 7.6 months median duration of response.
Responses were observed across all subgroups and irrespective of response to PD-1/L1.
Daniel Petrylak, study author presenting the results, a professor of urology at Yale, said the results were strong enough to support an accelerated approval.
This would involve the FDA granting a conditional licence that would be confirmed by a larger study, which is ongoing.

Some sobering findings of a study into sexual harassment and gender disparities highlighted at ASCO.
The anonymous email survey went out to 1,566 gynaecologists, with 402 responding.
There were 255 female respondents, 147 male respondents.
Overall, 64% experienced sexual harassment, occurring in 71% of women and 51% of men.
However only 14.5% reported sexual harassment.
Men were more likely to report no obstacles to advancement of their careers.
Study author Marina Stasenko said that low reporting rates were caused by some people thinking the incidents were not important.
“Some folks did not know who to report to, which was more than 20% of respondents”
“Certainly improving the pipeline of who to report to and how to report is very important.”
“Over 90% of respondents knew that there was a policy in their institution but only about 60% knew what the policy was. Increasing awareness will be vastly important.”

There have been a few shout-outs for ASCO’s efforts this year to support parents in general
Riyue Sunny Bao, PhD@RiyueSunnyBao
Hoping more conferences follow the great example of  – and ultimately boost the engagement of   !
Ishwaria Subbiah, MD MS@IshwariaMD
#ASCO19 rocks! Dr Annie Im MD (@annieimmcl) of @UPMCnews dropped of her “future members of @ASCO” at the on-site childcare to attend her morning sessions! She and they loved it! This is MEANINGFUL CHANGE for parents (of any gender) in medicine! #WomenInMedicine #medtwitter
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Fascinating press briefing this morning at ASCO.
Highlights were:
  • A study showing 60% of gynaecologic oncologists say they have experienced sexual harassment.
  • Results of a phase 2 trial of novel targeted-antibody treatment for advanced urothelial cancer
  • Using broader criteria for clinical trial enrolment would double number of eligible patients with lung cancer
  • A presentation from the FDA about expanding access to compassionate use programmes.
I will be providing more details shortly.

Kantar Health debates results from the KEYNOTE-062 trial
There were a number of debate-worthy outcomes from the KEYNOTE-062 trial that was presented at ASCO 2019 in Chicago yesterday.
The study looked at Merck & Co’s Keytruda as a first-line treatment for gastric cancer, and prompted questions about the meaningfulness of non-inferiority.
Kantar Health’s Debbie Warner and Michael Gaschler debate the results here.

A small biotech, MacroGenics, took the market by surprise earlier this year with some surprising data from its margetuximab – essentially a tweaked version of Roche’s Herceptin (trastuzumab) where a few amino acid mutations are enough to produce a stronger cellular response to cancer.
CEO Scott Koenig has been doing the rounds at the American Society of Clinical Oncology (ASCO) conference in Chicago following release of detailed data from the SOPHIA trial of margetuximab in breast cancer patients who have previously been treated with Herceptin and other similar medicines.

Tatiana Prowell, MD@tmprowell
This abstract deserves attn of all at this mtg, whether an  session chair or in the audience. Dr. @NarjustDumaMD et al analyzed assoc of race/gender & use of professional title during speaker intros at @ASCO mtgs. Hear full results Mon 2p in S100BC. cc @HemOncWomenDocspic.twitter.com/w1eLJuykpv
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A multiple myeloma showdown at ASCO 2019
Day three of ASCO 2019 saw a showdown on Sunday between two anti-CD38 compounds in multiple myeloma, Janssen’s Darzalex and Sanofi’s isatuximab. Kantar Health reviews the data.

Lynparza wows ASCO with pancreatic cancer data
Finding targeted therapies for pancreatic cancer has long been an issue for pharma, meaning that for decades the only real option has been a course of chemotherapy, with unpleasant side-effects and limited efficacy.
In most cases the prognosis even with chemotherapy is between eight and 12 months, a “dismal” situation according to Hedy Kindler, from Professor of Medicine at the University of Chicago.
Kindler was presenting data from the POLO study that is already being described as a game-changer for a small group of patients with the disease.

Kantar Health reviews results from phase 3 POLO trial
Anna Boudoures from Kantar Health reviews the “practice-changing” results of the phase 3 POLO trial of AstraZeneca and Merck & Co’s drug, as presented at ASCO 2019 in Chicago. Watch the video here.

ASCO pilots EHR standards
Cancer doctors in the US have launched a new scheme that aims to improve care by setting out electronic health record standards.
There are 15 million people with cancer in the US but many electronic health record systems use different terms to describe the same type of data, or collect data in different formats, making them incompatible.

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