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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The dog days of summer are usually quiet on the Pharmaland front, although this year has been a bit of an exception, being notable for a batch of deals being completed and announced already.
The cell therapy space is one area that has courted both controversy and new collaborations, for example. Nary a week seems to pass without something appearing in the news! This has proven pretty interesting for a number of subscribers, who write in asking plenty of astute questions.
Today’s questions from BSB readers therefore encompass allogeneic cell therapies and what’s going on in that fast moving dynamic space. Not all of the announcements may be what they seem though, and some are much more riskier than others.
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The race to the be first to market in the United States with a CD19 directed CAR-T cell therapy is a bit like the America’s Cup Challenge Race Series – one boat/company is ahead and then another is ahead, it’s an ever changing and fluid situation…
In this post, we’re looking at questions from subscribers – so what’s in the July BSB mailbag?
* CAR T Cell Therapy: Is the recent FDA hold – that came and went in record time, a setback to Juno? Who will win the CAR-T race to market in the United States? What is the market opportunity in Europe?
* Jounce/Celgene Deal: Celgene have a reputation for doing deals with innovative biotech companies, but then what? Is the Jounce deal a good one, or is it a value destroyer?
There are a few other questions in the mail bag, but the above gives you a flavour of some of the commentary in this post.
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Late this afternoon, Juno Therapeutics ($JUNO) announced (link to press release) that the FDA had put a clinical hold on enrollment into a phase 2 trial of their JCAR015 construct in relapsed refractory acute lymphoblastic leukaemia (ALL) in adults in the ROCKET Trial: NCT02535364.
The decision by the FDA was as a result of three recent patient deaths reported to be due to neurotoxicity. In after-hours trading the stock dropped 30% from a market close of $40.82, reaching an after hours low at time of writing of $26.66 at 4.43pm ET.
In this post we look at what happened, the possible reasons behind it, and what it may mean for other CAR T companies. A leading CAR-T cell expert also provided BSB with some commentary after the news broke.
Good News: Post now updated following FDA lifting hold on ROCKET trial.
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This morning, like many folks, I woke up to the latest immuno-oncology news on the bispecific front that Xencor, a Los Angeles based biotech, announced their latest collaboration, this time with Novartis.
Over the last few years, we have seen a surfeit of bispecifics emerge that are focused on stimulating the immune system, particularly with regard to T cells and natural killer (NK) cells, as well as antigen targets on the surface of tumours. The first one approved was Amgen’s blinatumomab (Blincyto), a CD19 targeted bispecific for the treatment of acute lymphoblastic leukemia (ALL), which we have written extensively about.
The Xencor/Novartis deal has a number of interesting implications that are well worth exploring in more depth that go far beyond the information provided in the press release.
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What questions are BSB readers sending in to us this month?
I wanted to take a moment out of AACR Previews and catch up on some recent news that is intriguing or perplexing subscribers. All questions are anonymous and in many cases, the same questions were actually sent in by multiple people, a testament to what’s top of mind in oncology lately.
Today, we cover a Q&A on a variety of topics on Kite Pharma (the Genentech collaboration and their TCR in solid tumours), a discussion about EGVRvIII in glioblastoma, and Gilead’s woes with idelalisib and an IO pipeline.
So let’s get started – subscribers can sign-in or you can sign up via the blue box below:
Yesterday, Juno Therapeutics and Celgene announced a ten year collaboration that is expected to close in July-August. In short, Celgene has exclusive right to entire the Juno portfolio in oncology and auto-immune cell therapy products in development outside North America and co-promote certain programs globally (not specified). Juno, meanwhile, gains the option to co-develop and co-promote select Celgene programs (also not specified).
You can see the terms of the deal here.
And listen to the webcast from the call after hours.
This news comes hot on the foot of an earlier announcement that the FDA accepted the Juno IND for JCAR017, a CD19 CAR T cell therapy being developed in relapsed/refractory NHL scheduled to initiate in 2015, with the possibility of a registration trial commencing in 2016.
What was fascinating, however, was the BioTwitter reactions last night – predictably, people either loved or hated the news – it clearly came as a surprise to many.
This morning my inbox is full of questions on this dramatic topic from subscribers, so here are some topline thoughts on this issue to answer the questions coming in.
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Over the last two years we’ve written extensively about chimeric antigen receptor (CAR) T cell therapies, checkpoint inhibitors and immune agonists (stimulants), yet these aren’t the only novel immunotherapies that are being developed to target cancer cells.
One area that hasn’t received a lot of attention is adoptive cell transfer (ACT) and therapeutic tumour infiltrating lymphocytes (TILs).
- What exactly are these approaches and what progress has taken place so far?
- Where is this field going in the near future?
To answer these questions, we put together a primer based on the groundbreaking research of Dr Steven Rosenberg (NCI Surgical Branch), and his invited talk at the recent American Society of Hematology (ASH) meeting.
As Rosenberg himself noted, what they’re doing is pretty daunting and yet, results so far have shown some impressive responses in some patients, especially those with metastatic melanoma, but other cancers have also responded well to this novel approach.
To learn more about this novel and very exciting approach, you can sign in or sign up in the box below.