Re: Farmas USA
TGTX (en realidad ha sido +90%)
TGTX Up 75% Today - GENUINEly Surprised by the Timing, not the Positive Results
GENUINEly Surprised by the Timing, not the Positive Results
Raymond James - March 6, 2017
Reni Benjamin, Ph.D., (212) 883-4615,
[email protected]
Bin Lu, Ph.D., Res. Assoc., (212) 883-6548,
[email protected]
Recommendation: We are reiterating our Strong Buy rating for TG Therapeutics given that the
Phase III GENUINE Study met its primary endpoint in both the intent-to-treat population and
the treated population. While we had been expecting a positive readout in May/June, our
belief in TG-1101’s additive therapeutic activity has been confirmed given that the absolute
ORR improvement of 33% achieved by TG-1101 plus ibrutinib over ibrutinib alone (80% vs
47%, P < 0.001) was significantly greater than the pre-specified threshold of 20%. Given the
positive GENUINE data, the potential for an accelerated approval in high-risk CLL, the potential
to initiate a Phase III MS program, the continued advancement of the UNITY-CLL Phase III
study, and a cash position of $44 million (pro forma), we continue to recommend shares to
risk-tolerant investors.
• Like bacon, everything is better with an anti-CD20. As a reminder, the pivotal Phase III
GENUINE Study (126 randomized patients) was designed to evaluate TG-1101 (an antiCD20
monoclonal antibody) plus ibrutinib vs ibrutinib alone in patients with previously
treated high risk chronic lymphocytic leukemia (CLL). The study met its primary endpoint
with TG-1101 plus ibrutinib achieving a statistically significant improvement in overall
response rate (ORR) compared to ibrutinib alone in the intent to treat (ITT) population
(p=0.001) as well as the treated population (80% vs 47%, P < 0.001). While nine and five
responders from both arms included in the primary analysis are awaiting additional
confirmation visits, in our opinion, these patients treated by the TG-1101 combo are likely
to maintain the responses given that it was infrequent (< 3% in the combination arm) for
initial responses to fail to be confirmed. In terms of safety, the combination was well
tolerated with a safety profile consistent with that established in the previous Phase II
study. The company plans to present the full data at a medical meeting (likely ASCO) in
1H17 and meet with FDA in 2H17 to discuss a potential BLA filling (1H18) for an
accelerated approval.
• FDA likes randomized trial results. While there is no doubt that the GENUINE study has
produced positive results, investors are likely to question whether the ORR data is robust
enough to support a potential accelerated approval. In our opinion, given that ibrutinib,
idelalisib, and venetoclax all gained one or more accelerated approvals based on ORR
results from single-arm studies (see Exhibit 1 for more detail), we believe there is high
likelihood for approval based on the randomized design and comparison with the
standard of care.
• Clinical investigator highlights unmet need and enthusiasm over results. During the call,
Dr. Anthony Mato from the University of Pennsylvania, a lead investigator of the
GENUINE trial, shared his perspectives, including: 1) The results are overwhelmingly
positive given that the high-risk population are the most difficult-to-treat CLL patients; 2)
The delta in the response rate shows the synergistic effect between TG-1101 and
ibrutinib, and it is not likely to decrease even if the response rate of ibrutinib as a single
agent may improve a little bit over time based on his experience of treating patients with
ibrutinib alone; 3) TG-1101 did not add much toxicity to ibrutinib aside from infusionrelated
reactions, which were infrequent and mild and have not caused a single
discontinuation among the patients he treated; 4) It is important to have another CD20
antibody which can add treatment benefits on top of ibrutinib given that the majority of
CLL patients would likely have failed on rituximab; and 5) Neither ibrutinib or venetoclax
represents a cure in the high-risk setting and both have poor responses as monotherapy
with venetoclax only reaching 3% MRD negativity in patients.
Company Description ____________________
TG Therapeutics, Inc., based in New York, New York, is a biotechnology company focused on commercializing
innovative therapies for the treatment of cancer and other large areas of unmet need. Currently, the
company is developing two advanced stage therapeutics: 1) TG-1101 (ublituximab) – a novel
glycoengineered monoclonal antibody targeting the CD20, an established target of monoclonal antibodies
including rituximab, obinutuzumab, and ofatumumab, all of which are currently approved for the treatment
of B-cell lymphomas and leukemias; and 2) TGR-1202 – an orally available PI3K delta inhibitor, another
validated target linked to the proliferation and survival of B-lymphocytes, and which culminated with the
approval of Gilead’s Zydelig. In addition, the company's pipeline also includes a PD-L1 inhibitor, a
GITR agonist, and an IRAK4 inhibitor
