Just spoke with Anders Bjartell, Professor of Urological Cancer, Lund University, Sweden about the data from the TITAN trial yesterday.
As a trial investigator he’s naturally really excited about the data, and he also raised some interesting points about the future of prostate cancer research. He agreed with the comments made in the oral presentation session yesterday about the need for more accurate testing to identify which mutations are present, as this has a big impact on prognosis.
Then I had a chat with Scott Koenig, CEO of Macrogenics about the company’s new breast cancer drug margetuximab. The biotech made waves ahead of the conference with data showing a survival benefit in patients previously treated with existing cancer drugs like Herceptin.
The company aims to file with the FDA based on the progression-free survival data, and will look to confirm this with further data next year about overall survival.
Right now that data is not ready but it will be interesting to see if the PFS benefit seen in the early data from the phase 3 SOPHIA trial translates into an overall survival benefit, and what the magnitude of that benefit will be.
I will be doing more in-depth coverage of these interviews on pharmaphorum later.
2 hours ago
ASCO launches mCODE to improve e-health record compatibility
ASCO has identified a huge issue that is holding back progress in cancer care – and it’s quite a basic problem.
Getting the disparate computer systems across the U.S. and the rest of the world to share electronic health record data effectively is a major problem, said ASCO president Monica Bertagnolli.
There are 15 million people with cancer in the U.S. 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.
According to ASCO this dramatically limits the ability of cancer researchers and doctors to learn from patient records, hinders care coordination, and adds to admin costs for all uses, but especially practices and patients.
Most patients assume that in these modern times it should be easy for doctors to communicate details about their disease and treatment.
But not so, according to Bertagnolli, as getting different systems to interact and read patients’ electronic records is proving to be a real challenge.
ASCO is trying to solve this problem with mCODE (Minimal Common Oncology Data Elements), a core set of data elements and recommended technical specs that it considers essential for capturing and reporting patient data, and should be captured in each patient’s electronic health record.
mCODE is a collaboration between ASCO, its wholly owned non-profit subsidiary CancerLinQ, and the Alliance for Clinical Trials in Oncology Foundation..
The standards and specs have been published online at mCODEinitiative.org.
Bertagnolli added in a question and answer session that it was her “dream” to make the system available worldwide to improve communication between oncologists on a global scale.
3 hours ago
ASCO experts noted that this and other data from immunotherapies is changing the way doctors think about patients with lung cancer.
The chances of patients surviving for extended periods of time with the disease have increased considerably.
In the past only a handful of lung cancer patients would survive past five years, but with immunotherapy around a quarter could be expected to live that long.
3 hours ago
New data unveiled at ASCO shows how Merck & Co’s Keytruda (pembrolizumab) and other immunotherapies could change the outlook for seriously ill lung cancer patients.
The latest data came from a phase 1a study, KEYNOTE – 001, which as its name suggests was one of the first cancer immunotherapy trials that began in 2011 in patients with solid tumours.
There were 550 people with advanced non-small cell lung cancer on the trial, including 101 patients who had not previously received any treatment and 449 who had received treatment previously.
After a median follow-up of 60.6 months – around five years – and at that point 18% of enrolees (100 people) were still alive.
Of those who had not received prior treatment, 23% were still alive after five years compared with 15.5% of those previously treated.
Higher levels of the biomarker PD-L1 predicted longest survival – in previously untreated people 29.6% with PD-L1 expression of 50% or more were alive after five years, compared with 12.6% with expression levels between one to 49%. Only 3.5% of people with expression levels below 1% were alive after five years.
Among previously treated patients, 42% had responses that lasted for a median of 16.8 months, while for those who were treatment naïve, 23% had responses that lasted for a median of 38.9 months.
3 hours ago
Another interesting point from that briefing on MONALEESA-7 – the survival data could also be important in countries carrying out health technology assessment to decide whether drugs should be available in national health systems.
ASCO expert Harold Burstein said: “Demonstration of robust survival adds to a value proposition for ribociclib and this could be helpful for health systems that measure value to decide on national access to drugs.”
Novartis looks to have gained an advantage in its battle with Pfizer and Eli Lilly in the CDK4/6 class of breast cancer drugs after its Kisqali became the first to show an overall survival benefit in a subgroup of younger patients.
Results of the phase 3 MONALEESA-7 trial found that adding Kisqali (ribociclib) to standard-of-care endocrine therapy significantly improved overall survival for premenopausal women with advanced HR-positive/HER2-negative breast cancer patients compared with endocrine therapy alone.
Data unveiled today at ASCO show the survival rate was 70% for women who took the combination therapy compared with 46% for women who received endocrine therapy only.
Women who received Kisqali lived a median 23.8 months without the disease progressing compared with 13 months for women who received placebo.
The trial was the first to focus exclusively on women under age 59 who were premenopausal and had advanced breast cancer for which they had not received prior endocrine therapy.
Investigators randomly assigned women to Kisqali or placebo and all received goserelin to suppress the oestrogen that drives the disease, and one of three other established therapies – letrozole, anastrozole, or tamoxifen.
In all, 672 women enrolled on the study and after a median follow-up of 34.6 months, 173 (26%) were still receiving the therapies, with 116 women still receiving Kisqali and 57 still receiving placebo.
Speaking at a press briefing to unveil the results, Sara Hurvitz, director of the Breast Cancer Clinical Research Program at UCLA, said that until now doctors were likely to use Kisqali, or Pfizer’s rival Ibrance (palbociclib) or Lilly’s Verzenio (abemaciclib) interchangeably.
But this could change with the survival data announced today – at least until Novartis’ rivals produce similar data, said Hurvitz.
Novartis’ data “could change the way physicians practice,” said Hurvitz at the press briefing in a question and answer session.
4 hours ago
Just came out of the morning press conference – I will have updates on new data from Novartis’ breast cancer drug Kisqali, and Merck & Co’s immunotherapy Keytruda shortly.
7 hours ago
AZ/Merck & Co reveal olaparib data in prostate cancer
PARP, or poly (ADP-ribose) polymerase, inhibitors may have an amusing-sounding name but an increasing body of evidence suggest they could be used in a wide range of cancers as long as certain mutations are present.
Data presented yesterday at ASCO 2019 from AZ and Merck & Co suggest their PARP inhibitor olaparib could be a potential competitor in metastatic castration resistant prostate cancer (MCRPC) with DNA damage repair mutations.
8 hours ago
ASCO 2019 – Kantar takes a first look at interim TITAN data
Will Erleada take the lead in metastatic CSPC? New interim data at ASCO 2019 from the phase 3 TITAN trial supports addition of Erleada to ADT for a broad range of patients in this setting.
8 hours ago
J&J’s early-stage prostate cancer data from Erleada
Johnson & Johnson is hoping to expand the use of its prostate cancer drug Erleada (apalutamide) in patients with metastatic castration-sensitive prostate cancer (mCSPC) – and new data presented yesterday at ASCO 2019 sheds light on the dossier under review at the FDA for this early stage disease.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.