Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT
Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced
statistically significant topline results from the pivotal phase 3
SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a
prostate-specific membrane antigen (PSMA)-targeted radioligand
therapy (RLT), in patients with metastatic castration-resistant
prostate cancer (mCRPC) after progression on an androgen receptor
pathway inhibitor (ARPI).
“There is an urgent unmet need for targeted treatment options
for mCRPC patients, particularly for those whose cancer has
progressed on androgen receptor pathway inhibitors,” said Dr. Kim
Chi, SPLASH Principal Investigator, Medical Oncologist, BC Cancer.
“The SPLASH study results demonstrate that 177Lu-PNT2002 is
well-tolerated and has the potential to play an important role in
addressing those needs for patients with chemotherapy-naïve
mCRPC.”
The SPLASH trial met its primary endpoint, demonstrating a
median radiographic progression-free survival (rPFS) per blinded
independent central review of 9.5 months for patients treated with
177Lu-PNT2002, compared to 6.0 months for patients treated with
ARPI in the control arm, a statistically significant 29% reduction
in the risk of radiographic progression or death (hazard ratio [HR]
0.71; p=0.0088). At the time of the analysis, interim overall
survival (OS) results were immature (46% of protocol-specified
target OS events reached), the HR was 1.11. The companies expect
additional, follow-up data in 2024 prior to the potential
submission of a New Drug Application (NDA).
177Lu-PNT2002 demonstrated a favorable safety profile with grade
≥3 treatment-emergent adverse events (TEAEs) per Common Terminology
Criteria for Adverse Events (CTCAE), serious TEAEs, and TEAEs
leading to discontinuation occurring at lower rates in the
177Lu-PNT2002 arm than in the ARPI arm (30.1%, 17.1%, and 1.9% vs.
36.9%, 23.1%, and 6.2%, respectively).
|
177Lu -PNT2002 Arm |
ARPI Arm |
TEAEs of CTCAE Grade ≥3 |
30.1% |
36.9% |
Serious TEAEs |
17.1% |
23.1% |
TEAEs Leading to Discontinuation |
1.9% |
6.2% |
The open-label study randomized 412 patients with
PSMA-expressing mCRPC who had progressed on ARPI therapy and either
refused or were not eligible for chemotherapy, in a 2:1
randomization ratio (177Lu-PNT2002: control group). At the time of
the analysis, 84.6% of patients who experienced progressive disease
in the control arm subsequently crossed over to receive
177Lu-PNT2002. SPLASH was conducted across the United States,
Canada, Europe, and the United Kingdom. Eighty percent of SPLASH
patients resided in North America and approximately 10% of all
participants were Black or African American.
"The success of 177Lu-PNT2002 in this trial demonstrates the
value of treating patients with radioligand therapy at this stage
of the disease continuum. With only four treatment administrations
over a 32-week period, this regimen provides reduced treatment
intensity compared to the control arm, while also delaying disease
progression with lower toxicity,” said Neil Fleshner, M.D.,
Co-founder and Chief Medical Officer at POINT Biopharma. “We extend
our deepest gratitude to the SPLASH study participants and their
families and caregivers, as well as the investigators and their
hard-working staff."
“We are encouraged by the results of the SPLASH trial, which
showed the benefits that 177Lu-PNT2002 offers to patients with
mCRPC. We are proud to be at the forefront of advancing the
potential of targeted RLT with 177Lu-PNT2002. As the leading
radiopharmaceutical-focused company, we are committed to providing
clinicians with cutting-edge options to fight disease and improve
patient outcomes,” said Jean-Claude Provost, M.D., Chief Medical
Officer at Lantheus. “We look forward to sharing additional data in
the future, and to collaborating with regulatory authorities and
POINT Biopharma to bring this promising therapy to the prostate
cancer patient community.”
Full SPLASH trial results will be presented at a future medical
congress.
About the SPLASH TrialThe phase
3 SPLASH trial is a multicenter, randomized, open label assessment
of 177Lu-PNT2002 in patients with PSMA-expressing mCRPC who have
progressed on ARPI therapy and refuse, or are not eligible for,
chemotherapy. The randomization phase of the study randomized 412
patients across North America, Europe, and the United Kingdom.
Patients were randomized 2:1 with those in arm A receiving
177Lu-PNT2002 and those in arm B receiving either abiraterone or
enzalutamide. Patients in arm B who experience centrally assessed
radiographic progression and meet protocol eligibility have the
option to crossover and receive 177Lu-PNT2002. Patients will be
followed for up to 5 years from their first 177Lu-PNT2002 dose. The
primary endpoint of the study is radiographic progression-free
survival. More information about the trial is accessible at
www.ClinicalTrials.gov, identifier NCT04647526.
About
177Lu-PNT2002177Lu-PNT2002 is a
PSMA-targeted, lutetium 177-based radioligand therapy candidate
that combines a PSMA-targeted ligand, PSMA-I&T, with the
beta-emitting radioisotope no-carrier-added lutetium-177. Lantheus
Holdings, Inc. in-licensed exclusive worldwide commercialization
rights (excluding certain Asian territories) to 177Lu-PNT2002 from
POINT in December of 2022. In April of 2023, the FDA granted Fast
Track designation for 177Lu-PNT2002 for the treatment of mCRPC.
Fast Track is a process designed to facilitate the development and
expedite the review of drugs to treat serious conditions and
address unmet medical needs.
About Prostate Cancer
Prostate cancer is the second most common form of cancer
affecting men in the United States -- an estimated one in eight men
will be diagnosed with prostate cancer in their lifetimes. The
American Cancer Society estimates that in 2023, almost 288,300 new
cases of prostate cancer will be diagnosed, and about 34,700 men
will die of the disease.1
About Lantheus Lantheus is the leading
radiopharmaceutical-focused company, delivering life-changing
science to enable clinicians to Find, Fight and Follow disease to
deliver better patient outcomes. Headquartered in Massachusetts
with offices in New Jersey, Canada and Sweden, Lantheus has been
providing radiopharmaceutical solutions for more than 65 years. For
more information, visit www.lantheus.com.
About POINT BiopharmaPOINT Biopharma Global
Inc. is a globally focused radiopharmaceutical company building a
platform for the clinical development and commercialization of
radioligands that fight cancer. POINT aims to transform precision
oncology by combining a portfolio of targeted radioligand assets, a
seasoned management team, an industry-leading pipeline, in-house
manufacturing capabilities, and secured supply for medical isotopes
including actinium-225 and lutetium-177. Learn more about POINT
Biopharma Global Inc. at https://www.pointbiopharma.com/.
Safe Harbor for Forward-Looking and Cautionary
StatementsThis press release contains “forward-looking
statements” that are subject to risks and uncertainties.
Forward-looking statements include, but are not limited to,
statements relating to the potential of PNT2002 and statements
regarding Lantheus’ and POINT’S expectations, hopes, beliefs,
intentions or strategies regarding the future. In addition, any
statements that refer to projections, forecasts or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking statements.
Forward-looking statements may be identified by their use of terms
such as "expected,” “look,” “planned,” “potential,” “will,” and
other similar terms. Such forward-looking statements are based upon
current plans, estimates and expectations that are subject to risks
and uncertainties that could cause actual results to materially
differ from those described in the forward-looking statements.
Risks and uncertainties that could cause our actual results to
materially differ from those described in the forward-looking
statements include (i) the outcome of the SPLASH trial after full
data is available; (ii) a delay in obtaining, or failure to obtain,
a positive regulatory outcome from the FDA and regulatory
authorities for PNT2002; (iii) the additional costs and risks
associated with Lantheus’ ability to successfully launch PNT2002 as
a commercial product; (iv) the market and patient receptivity to
PNT2002 as a radiopharmaceutical therapy; (v) the existence,
availability and profile of competing products and therapies; (vi)
Lantheus’ ability to obtain and maintain adequate coding, coverage
and payment for PNT2002; (vii) the intellectual property protection
of PNT2002; (viii) POINT’s ability to successfully develop and
scale the manufacturing capabilities to support the launch of
PNT2002; and (ix) the risks and uncertainties discussed in
Lantheus’ and POINT’s filings with the Securities and Exchange
Commission (including those described in the Risk Factors section
in their Annual Reports on Form 10-K and their Quarterly Reports on
Form 10-Q).The inclusion of forward-looking statements should not
be regarded as a representation that such plans, estimates and
expectations will be achieved. Readers are cautioned not to place
undue reliance on the forward-looking statements contained herein,
which speak only as of the date hereof. Neither Lantheus nor POINT
undertakes any obligation to publicly update any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as may be required by law.
Additional Information and Where to Find itIn
connection with the proposed acquisition of POINT, Eli Lilly and
Company (“Lilly”) caused its acquisition subsidiary to commence a
tender offer for all of the issued and outstanding shares of common
stock of POINT. This communication is for informational purposes
only and is neither an offer to purchase nor a solicitation of an
offer to sell any securities, nor is it a substitute for the tender
offer materials that Lilly and its acquisition subsidiary filed
with the SEC upon commencement of the tender offer. A solicitation
and offer to buy outstanding shares of POINT is being made only
pursuant to the tender offer materials that Lilly and its
acquisition subsidiary have filed with the SEC. Lilly and its
acquisition subsidiary have filed with the SEC a tender offer
statement on Schedule TO, and POINT has filed a
Solicitation/Recommendation Statement on Schedule 14D-9 with the
SEC with respect to the tender offer. THE TENDER OFFER MATERIALS
(INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL
AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE
SOLICITATION/RECOMMENDATION STATEMENT CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO. INVESTORS
AND STOCKHOLDERS OF POINT ARE URGED TO READ THESE DOCUMENTS
CAREFULLY (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO
TIME) BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND
STOCKHOLDERS OF POINT SHOULD CONSIDER BEFORE MAKING ANY DECISION
REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE TENDER
OFFER. The tender offer materials (including the Offer to Purchase
and the related Letter of Transmittal) are available to all
stockholders of POINT at no expense to them at Lilly’s website at
investor.lilly.com. The information contained in, or that can be
accessed through, Lilly’s website is not a part of, or incorporated
by reference in, this press release. The tender offer materials
(including the Offer to Purchase and the related Letter of
Transmittal), as well as the Solicitation/Recommendation Statement,
are also available for free on the SEC’s website at www.sec.gov. In
addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement, Lilly and POINT file
annual, quarterly, and current reports, proxy statements and other
information with the SEC. You may read any reports, statements or
other information filed by Lilly and POINT with the SEC for free on
the SEC’s website at www.sec.gov.
1. American Cancer Society. Facts & Figures
2023. American Cancer Society. Atlanta, GA. 2023
Contacts: LantheusMark
KinarneyVice President, Investor
Relations978-671-8842ir@lantheus.com
Melissa Downs Senior Director, External
Communications646-975-2533media@lantheus.com
POINT BiopharmaDaniel PearlsteinDirector,
Strategyinvestors@pointbiopharma.com
POINT Biopharma Global (NASDAQ:PNT)
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