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 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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One of the hot topics at the forthcoming 2016 annual meeting of the American Association for Cancer Research (AACR) in New Orleans is likely to be CAR T cell therapy (Twitter: #AACR16).
Several research groups have shown impressive results in acute lymphoblastic leukaemia (ALL), but challenges remain in using adoptive cell therapy to treat other leukemias such as CLL, as we heard from Dr Porter at the recent BMT Tandem meeting. See post: Challenges and Opportunities of CAR T cell therapy in CLL. Perhaps more significantly, there’s a long way to go before CAR T cell therapies hit prime time in solid tumours.
What is fascinating is the pace of scientific research in the field. By the time the first CAR-T cell therapy is FDA approved, the second generation constructs used in them will most likely be obsolete.
This post reviews completely new research, which we’ve not written about before, that I expect we’ll hear more about at AACR, and discusses novel concepts about how to make CAR T cell therapy more effective in both leukemia and solid tumours. It’s a good pre-AACR preparation for those interested in cancer immunotherapy and the emerging CAR T cell therapy landscape.
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It’s Tuesday at the 2016 JP Morgan Healthcare conference in San Francisco (Twitter #JPM16).
Each day of #JPM16 we’re doing a rolling blog post which we’re updating throughout the day with commentary and insights on the company presentations we’re covering.
While we’re not giving a blow-by-blow account, many companies have the slides readily available, we will be commenting on noteworthy news, and what we learn about corporate strategy going into 2016.
For those of you who like to catch up with the final summary of each day’s highlights, you can read yesterday’s Day 1 synopsis here and our interview with Seattle Genetics CEO, Clay Siegall here.
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It’s that time of the month where the BSB readers get their chance to put us on the hot spot!
Here, we take a look at reader questions that have been submitted and argue the toss – is there evidence preclinically or clinically that is useful or instructive?
We can’t promise to answer every question, sometimes there simply isn’t any data to help either way.
This week, the topic is CAR T cell therapies, a subject that seems to be very high on many people’s minds and many of you had similar questions, so here goes…
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A regular reader of BSB wrote in asking for an update on Amgen’s blinatumomab, an anti CD3/CD19 bispecific antibody being investigated in B cell adult acute lymphoblastic leukemia (B-ALL) and Non Hodgkins Lymphoma (NHL). It has orphan designation for both indications.
Amgen acquired Micromet and their BiTE program way back in January 2012. At the time, the R&D head, Roger Perlmutter, referred to the exploratory phase II results as being a key driver for their interest in the technology. Like many, I too, was initially enthusiastic about the bispecific antibody when it was with Micromet, since those were very encouraging results in refractory adult ALL, a particularly hard to treat malignancy with a generally poor prognosis.
Unfortunately, since then we’ve heard very little about the program, which seems to have languished in the Amgen portfolio, a not uncommon occurrence when big Pharma/Biotech take over small biotech programs. In the meantime, chimeric antigen receptor (CAR) T cell therapies have arrived to much fanfare, and with it, even more dramatic results that have caught people’s attention.
Is there still a future for blinatumomab and BiTE technology?
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One of the fun aspects of the American Society of Hematology (ASH) conference last month was interviewing several thought leaders and CEOs about the latest developments that were emerging rapidly almost every single day. Now, some medical meetings can be rather dreary if there’s no new or exciting data to pique the interest of the foot weary attendees, who tend to run on coffee and adrenalin for four days, but this ASH was rather different.
Looking at the program the first morning, I realised that I hadn’t felt so much anticipation since the 1999 meeting, when the phase I imatinib (Gleevec) data was presented in the plenary session by Brian Druker. This time around there was a lot of buzz in so many areas from CLL and NHL to myeloma and ALL, it was pretty exciting to run from session to and see many packed rooms filled with an air of expectancy. One evening, I hesitated at the top of an escalator and dithered over which of three very interesting sessions to dash to, as a bunch of researchers crashed into me all distracted by the exactly same dilemma!
If many of us could have made one request of the ASH organising committee it was clearly start offering a virtual meeting for all the oral sessions, something ASCO do incredibly well.
At ASH if you miss a presentation, it’s gone forever.
This is quite a pain if you really wanted to see the data from Agent X in CLL, Compound Y in CAR T cells and Drug Z in myeloma, as well as the one you actually attended. All those sessions ran simultaneously. It also means the sessions are still running at 7pm (yes, they were still packed even at that hour!) and many of us had an early start with 7am sessions or meetings.
The huge distances between rooms (#blisterruns), coupled with a stubborn insistence in putting almost all the oral sessions on Monday and Tuesday, together with long waits between interesting sessions over the weekend, makes for a very frazzled and disjointed schedule. Patience and stamina are the name of the game here.
Here we highlight our latest thought leader interview on CAR T cell therapy.
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