San Francisco: A look at what’s new in gastric cancer (GC) from the 2017 ASCO GI meeting.
Day 1 of #GI17 is filling up…
There were several phase 3 trials presented in GC and gastro-esophageal junction (GEJ) carcinoma in both targeted therapies and immunotherapies this past weekend.
- When we look carefully at the latest data, what do we find?
- Where are the opportunities and challenges in this niche?
Another critical question that many observers will be interested in is…
Will BMS’s checkpoint inhibitor, nivolumab (Opdivo), overcome recent setbacks in lung cancer and make a mark in stomach cancer to challenge approved targeted therapies such as ramucirumab (Cyramza)?
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Some cancer conferences attract more questions and queries than others.
Old Town San Diego
Interestingly, ASH is always a popular meeting for attendees and readers alike, so it is good to see another batch of critical questions come in so soon after the last one. It’s a while since we did two BSB reader Q&A mailbags from a single meeting!
Not surprisingly, there were also a bunch of questions on CAR T cell therapies, which continue to dominate readers minds, as well as related issues. Here, we answer the most pressing questions that have come in over the last week.
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San Diego – Monday at the 2016 Annual Meeting of the American Society of Hematology (#ASH16) is typically a day of multiple oral sessions in parallel.
This year it was a major challenge doing a mad dash between sessions as the meeting is now so big that in San Diego it’s being held, not only at the vast convention center, but is also using the meeting rooms of three nearby three hotels – it’s literally a mile walk to go from one end of the convention to the other, so you have to factor that time into your crazed schedule with multiple clashes.
On the positive side, there’s even courtesy pedicabs – cycle rickshaws (great idea & fun) – I caught one at 7am the other day to save my toes from at least one #blisterwalk…
Following on from our ASH Highlights 2016 Part 1, this post answers critical BSB Reader questions that have come in thick and fast and require more than 140 characters on Twitter to answer.
Predictably, the majority of the first tranche of questions have been CAR T cell therapy related, so if you have a keen interest in this area, this is the post for you. We tackle 5 critical questions and offer some insights.
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San Diego – after “Flying Friday” where I flew from Munich to San Diego, Biotech Strategy Blog coverage of the 2016 annual meeting of the American Society of Hematology (ASH) is now done for another year.
With over 27,000 attendees – it’s the largest ASH annual meeting I’ve seen in 20 years of coming here! ASH is definitely the pre-eminent global meeting for hematology and blood cancers.
As you might expect, the thought leaders at this event are super-busy, but we’ve already managed to catch up with a few, and we’ll be rolling out interviews in the “post-game show.”
Subscribers have been asking what’s really hot at ASH this weekend, so reflecting my interests and the sessions I went to, here are my seven highlights/learnings of ASH 2016 (so far). There’s a lot more data to come!
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This is an important and necessary follow-up to the ongoing Juno JCAR015 story in July after three patients had died due to complications associated with cerebral oedema. At that time, the company attributed the deaths to the inclusion of fludarabine in the lymphodepletion given prior to CAR T cell therapy infusion, leading to severe neurotoxicity, and clinical hold was lifted by FDA after the protocol was subsequently amended.
This morning came the dramatic announcement that following the protocol amendment, Juno has voluntarily placed the ROCKET trial on clinical hold again following another two deaths from cerebral oedema.
What gives and what are the consequences here?
We take a joint look at some of the issues that arise from this situation in terms of the CAR T cell therapy market and also pen thoughts from the analyst call this morning.
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Post 2016 US Election, we move on and get back to business with an in-depth review of some new science and clinical data.
Yes, it’s time for another Bushidō – “Way of the Warrior” – guide to the key ASH abstracts!
Here we focus on acute myeloid leukemia (AML), a difficult and challenging disease to treat with a high unmet medical need for new effective therapies.
In this Preview we look at key companies in the AML space, as well as a look at what’s happening in classic targets and also some new ones that are receiving notable attention, both preclinically and also in the clinic.
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It was only five years ago that the number of abstracts on CAR T cell therapies at the American Society of Hematology (ASH) ran to a dozen or less. Fast forward to 2016 and we now have tens of them, almost too many to count, let along review quickly and easily.
A scene from ASH 2015…
To give you an idea of the staggering speed of progress, in 2010 it took me less than half an hour to search and read all the CAR T cell abstracts, now it takes nearly a whole day to peruse and review them carefully.
We can’t resist a challenge…
As usual, we will write in more depth from the meeting as the data emerges in real time since many of the abstracts are often placeholders with updated information provided at the conference itself.
For now, here we provide an in-depth preview of the CAR T cell landscape in terms of the players, the products, new scientific research, biomarkers, emerging trends and more in a handy What to Watch For (W2W4) guide on key areas to expect at ASH to enable better enjoyment and awareness as the data rolls out next month.
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After some relatively quiet summer months, we have been deluged with questions and requests this month for commentary on some hot topics of late. This seems like a good time to take stock and reflect on some of most frequent ones sent in.
The original Journal Club post slated for today will appear next week instead.
Here, we address numerous queries on the following five topics readers are interested in:
- APHINITY trial in HER2+ adjuvant breast cancer
- Array’s BRAF plus MEK data in metastatic melanoma
- Kite’s interim ZUMA–1 phase 2 announcement
- Amgen’s Kyprolis in newly diagnosed multiple myeloma
- BMS nivolumab data in 1L lung cancer (CheckMate-026)
The last two in particular seem to be causing a lot of hand-wringing!
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There was a time when it seemed that all the good news emerging in cancer research was on breast cancer, that is clearly no longer true as other tumour types have seen some leaps and bounds with different modalities, including areas previously thought to be a graveyard for big Pharma, such as metastatic melanoma, for example.
New Dawn at the Houses of Parliament
That said, after the excellent developments in hormone-sensitive disease and the identification of the HER2 oncogene, we now have CDK4/6 as a validated target in metastatic breast cancer.
Pfizer’s palbociclib (Ibrance) lead the way, with two approvals in previously untreated and relapsed ER+ HER2- advanced breast cancer. Two other companies in this field are Novartis with ribociclib and Lilly with abemaciclib. Data is being presented on all three therapies at ESMO this year.
In addition, there are some other abstracts of note that are well worth discussing.
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In our ECCO Preview series last year (note: ESMO and ECCO have alternated the EU major cancer conference in the Fall for years), we highlighted several promising novel agents in development including the following:
- StemCentRx’s anti-DLL3 inhibitor: rovalpituzumab tesirine (ROVA-T)
- Ignyta’s Pan Trk, ROS1 and ALK inhibitor: entrectinib
- Pfizer’s anti-NOTCH3 inhibitor: PF–06650808
- Pfizer’s PTK7 ADC in TNBC: PF–06647020
What happened to them all? Were they good selections or not?
Well, AbbVie acquired StemCentRx in a $10.2B deal, Ignyta are busy advertising their new clinical trial enrollment for entrectinib as a non-chemotherapy and non-placebo controlled study on social media, suggesting that compound’s clinical development is still very much alive, while both the Pfizer compounds are also still active, as far as I know.
None have yet been consigned to dog drug heaven, which is quite something considering the failure rate in oncology drug pipelines!
Indeed, last year the Pfizer PTK7 ADC data was focused on triple negative breast cancer, where there is a solid rationale. This time around, the same research group explore the latest activity in advanced solid tumours, including ovarian cancer, as mentioned in the earlier Preview (See: 9 key abstracts in Ovarian Cancer).
So it’s time to sit down and chew the fat on one of my favourite topics at conferences – Development Therapeutics.
Here we consider which other compounds – other than the Pfizer ADC – that are worthy of highlighting and watching out for this year?
There are certainly some curious and quite different (i.e. novel) approaches to look at.
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