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Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘AZD9291 vs rociletinib’

Chicago – it’s Monday at ASCO 2015, with a full day of symposia, oral abstracts and posters here in Chicago.

Yesterday in the Plenary Session here at ASCO, Dr Jedd Wolchok (Memorial Sloan Kettering Cancer Center) presented the results of the Checkmate 067 trial (LBA1) – the results of a phase III trial of nivolumab (NIVO) alone combined with ipilimumab (IPI) versus IPI alone in treatment naive patients with advanced melanoma. You can read more about this in our ASCO Day 3 highlights.

Dr Wolchok is pictured below, prior to presenting at the ASCO 2015 press briefing.

Dr Jedd Wolchok ASCO 2015 Press Briefing

Checkpoint inhibitors have been a real buzz at this meeting, but with the realization that they are not going to work in all patients, and other treatments are not going away… for all the promise there’s still a lot of work to do optimize cancer immunotherapy.

There’s also been a lot of talk at ASCO about PD-L1 as a biomarker, and if you haven’t already done so, do check-out Episode 2 of the Novel Targets podcast (The Immune Biomarker Show) that touches upon many of the key issues.

If you haven’t already done so, do check out yesterday’s post on the metastatic lung cancer session, including the AZD9291 vs. rociletinib race to market in T790M, because there was some interesting new data presented that will likely have an impact today.

What’s hot on Monday at ASCO 2015? This will be the last of our daily posts from ASCO 2015. Subs can login to read our highlights as the day progresses. We’ll update schedule permitting.

European Lung Cancer Conference 2015Geneva – at the 2015 European Lung Cancer Conference today, Pasi A. Jänne, MD, PhD presented updated progression free survival and duration of response data for the phase 1 AURA trial of AZD9291 (AstraZeneca) in patients with EFGR-TKI-resistant advanced non-small cell cancer (Abstract LBA3).

Dr Jänne (pictured below at ASCO 2014) is Director, Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Medical School.

Dr Pasi Jänne ASCO 2014

It’s hard to believe that it is only about two years since the first patient was enrolled in the phase 1 AURA trial of AZD9291, a third generation EGFR inhibitor. If the FDA regulatory submission takes place, as expected, in the second quarter of this year, then the drug could be approved for sale in the United States before the year end.

It has been fascinating to watch the race to market between rociletinib (Clovis Oncology) and AZD9291. It’s likely both could be approved in the United States before the year end.

That would be great news for lung cancer patients, given the absence of any approved therapy for patients who develop a T790M mutation and become resistant to EGFR inhibitors, such as Tarceva and Iressa.

Readers will know that we have been following the phase 1 AURA trial of AZD9291 since ECCO 2013 in Amsterdam, when the first clinical data was presented.

AstraZeneca are to be congratulated on what is a case study of rational scientific drug development; their path to market strategy highlights the benefit of well-designed early clinical trials. AZD9291 may end up receiving regulatory approval less than three years from the start of the first in man trial – that’s tremendous!

I had the privilege to interview Dr Jänne at ASCO last year, and again earlier this week, before he left Boston for Geneva and chatted with him about his AZD9291 presentation at European Lung.

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