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JP 摩根-美股-生物科技行业-美国生物科技行业深度研究-4-99页.pdf
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JP 摩根-美股-生物科技行业-美国生物科技行业深度研究-4-99页.pdf
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www.jpmorganmarkets.com
North America Equity Research
10 April 2019
US Biotechnology
Updated Deep Dive: The BCMA Drum Beats On;
What to Expect Over the Next 12+ Months - ALERT
Biotechnology – Large Cap
Cory Kasimov
AC
(1-212) 622-5266
cory.w.kasimov@jpmorgan.com
Bloomberg JPMA KASIMOV <GO>
Matthew T Holt, Ph.D.
(1-212) 622-9602
matthew.t.holt@jpmorgan.com
Carmen Augustine, CFA
(1-212) 622-8527
carmen.augustine@jpmorgan.com
J.P. Morgan Securities LLC
See page 96 for analyst certification and important disclosures.
J.P. Morgan does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the
firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in
making their investment decision.
Following ASH and ahead of a busy period for the BCMA space (including two
pivotal data sets and a continuing deluge of earlier-stage data), we wanted to update
our BCMA deep dive (deck attached & linked here). There has been some separation
(as evidenced by a couple program discontinuations), but it’s still way too early to
crown any clear winners. Nevertheless, we believe BLUE remains well positioned. In
our attached SLIDE DECK we include: (1) a comprehensive overview of the BCMA
landscape; (2) detailed data sets updated post-ASH; and (3) comparisons to current
treatments in r/r MM. Bottom line, the BCMA space continues to be competitive with
further data updates starting in mid-2019. However, with a high bar already set,
longer-term durability data (not expected until late 2019/2020 at the earliest) will be
key to any therapeutic/modality differentiation.
BLUE remains well positioned despite the growing wave of competition.
BLUE’s bb2121 CAR T remains in the lead in terms of timing and overall strength
of clinical profile, with pivotal data expected in 2H19 and a BLA filing shortly
thereafter. It is neck and neck with GSK’s ‘916 antibody-drug conjugate (ADC),
with pivotal data also expected in 2H19. At this point, we’re aware of >30 CAR
T/ADC/bispecific programs targeting BCMA, and many will have data over the next
12+ months.
CAR Ts have produced the most compelling data sets to date... Notwithstanding
the normal caveats of cross-trial comparisons, when looking at the data presented at
ASH and more mature data sets, CAR T therapies (e.g., bb2121, LCAR-B38M) have
produced the best results to date, in our view. We see this as a high bar for future
development.
…though it is becoming clearer that not all BCMA CAR Ts are created equal.
Though it is too early to pronounce winners, there is some evidence of separation
between BCMA CAR T candidates (and potentially other modalities) given recent
events. Indeed, both GILD and NVS have discontinued their initial programs and
instead will focus on dual/multi-target approaches.
In the likely event that more than one BCMA therapy makes it to market, we
continue to see room for multiple players. Given the unmet need in patients who
are high risk, not eligible for transplant, or who have failed several therapies, we do
see room for multiple players / modalities within the MM space, though there is the
ongoing commercial question that CARs still need to answer. That said, we believe
that a combination of efficacy, safety, and dosing convenience / combinability will
play a role in the how this plays out in the likely event that multiple therapies make
it to market. We also note that there’s an ongoing push in the clinic to move BCMA
targeted therapies earlier in the treatment paradigm.
2
With multiple BCMA-directed therapies making their way through the clinic for multiple myeloma, we are providing an
update on the competitive landscape and expected catalysts over the next 12+ months.
By our count, there are >30 BCMA-directed therapies either in or advancing towards the clinic
These can be divided into CAR T therapies (both autologous & allogeneic) and biologic-based approaches (e.g. bispecifics & antibody-drug
conjugates, or ADCs) that each comprise ~50% of the landscape
Though it’s difficult to crown one therapy (or even modality) as best-in-class given the early-stage of development (even
following a very busy ASH), CELG/BLUE’s bb2121 and GSK’s ‘916 remain neck and neck in the race for first-to-market…
In our view, durability remains the most important consideration, and we’ll need to wait until late 2019/2020 (…at the earliest) to have a better
understanding of how BCMA therapies stack up
That said, pivotal data for bb2121 & ‘916 in 2H19 are the key 2019 catalysts to watch; we suspect these will inform future BCMA development
…and though initial datasets from these programs have set the bar very high, we ultimately see room for multiple
players.
We do see room for multiple players / modalities within the MM space given the unmet need in patients that are high risk, not eligible for
transplant, or who have failed several therapies
We expect a combination of efficacy, safety, and dosing convenience / combinability to determine how this plays out commercially in the likely
event that multiple therapies / modalities make it to market
Following a plethora of datasets at ASH, it’s still too early to pronounce winners…although there is some evidence of separation b/w candidates
(as evidenced by a couple of program discontinuations)
Within this deck, you’ll find:
A brief introduction to BCMA & CAR T / biologic modalities
An updated & detailed review of the more mature datasets thus far, including data presented at ASH 2018
A brief overview of multiple myeloma and historical data in the relapsed and refractory multiple myeloma setting
Overview of the BCMA Landscape: Executive Summary
3
ASH 2018 was rife with BCMA data sets, although the conference (as expected) offered limited visibility into eventual
competitive positioning…
There were >50 ASH abstracts relevant to BCMA-directed therapies
What we saw included initial clinical data for many CAR T constructs (and a few biologic approaches) with a focus on response rates and safety
given the limited follow-up for most of these programs
See our BCMA-related ASH takeaways (here and here)
…however, it is becoming increasingly clear that not all BCMA CAR Ts are created equal, with two major players pressing
the reset button after disappointing initial attempts…
Novartis has moved away from pursuing a BCMA CAR T monotherapy and will instead look at combination approaches with CD19-directed CAR T
therapies
At our Healthcare Conference, Gilead noted that their KITE-585 BCMA CAR-T therapy “was not as good as competitors” and is planning a dual
targeted approach to improve outcomes (specific details TBD)
…and there were a few other updates and smaller deals that occurred post-ASH as well
GSK completed enrollment for the GSK ‘916 pivotal in 4L patients earlier than expected and now is guiding to a 2H19 readout with a BLA
submission by YE19 (this was accompanied by a publication for the initial Phase 1 / 2 study with an updated mPFS of 12 months vs. the previous
7.9 months at the interim)
A CT.gov update for CELG’s CC-93269 bispecific indicates that development plans may have changed. The Phase 1 study is now listed as “active,
not recruiting” with only 19 patients enrolled (vs. an original target of 125 pts)
BLUE continues to expect trial initiations for bb2121 in the 2
nd
and 3
rd
line in r/r MM in 1H19
ABBV partnered with little known Teneobio to develop their BCMA-targeted bispecific TNB-383B (the initiation of clinical studies is expected in
1H19)
So What’s New Since the Last Update?
4
Intro to BCMA and CAR T / biologic modalities...…………………………………..…………………….………………....5
The BCMA-directed treatment landscape in multiple myeloma – An Overview………………………………..9
CAR T BCMA Approaches……………………………………………………….………….............................................16
BLUE: bb2121 data in relapsed/refractory multiple myeloma………...…….............................................17
BLUE: bb21217 data in relapsed/refractory multiple myeloma………….….............................................27
CELG: JCARH125 data in relapsed/refractory multiple myeloma..….……...............................................34
JNJ / Legend Nanjing: LCAR-B38M data in relapsed/refractory multiple myeloma…..……....................42
Advanced Biologic BCMA Approaches……………………………………………………….…………..........................50
GSK: GSK ‘916 data in relapsed/refractory multiple myeloma………….…...…………..….....…………………….51
AMGN: AMG420 data in relapsed/refractory multiple myeloma.……….……….…………..……………..……...59
Multiple myeloma overview..………………………………………………………………………….…………………………....66
Appendix 1: What’s the current bar in relapsed/refractory multiple myeloma?.....………………..….....69
Appendix 2: Clinical trials with BCMA-directed therapies.……….…………..……..…………………………….....80
Table of Contents
5
Intro to BCMA and CAR T / biologic modalities
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