Investor Presentation

On August 31, 2021, Kintara Therapeutics, Inc Presented the Corporate Presentation (Presentation, Kintara Therapeutics, AUG 31, 2021, View Source [SID1234587382]).

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Immunolight, LLC Receives FDA Clearance to Initiate Phase 1 Trial of the X-PACT System in Solid Tumors

On August 31, 2021 Immunolight, LLC, a clinical stage biopharmaceutical firm leading the way in advancing technologies to transform cancer treatment, reported it has received FDA clearance to enter phase 1 study in patients with breast, melanoma, sarcoma and head and neck cancers (Press release, Immunolight, AUG 31, 2021, View Source [SID1234587075]).

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The heart of the X-PACT (X-ray Psoralen Activated Cancer Treatment) system is psoralen, a naturally occurring compound which has been successfully used for decades in the treatment of autoimmune disease, skin disorders and certain skin and blood cancers. It has not, however, been able to be used to treat solid tumors due to the fact that UV light, which is needed to activate psoralen, cannot penetrate through tissue to reach the solid tumors. Immunolight has now made that possible.

Immunolight innovated materials that convert tissue penetrating energies, such as low dose X-ray, into UV light inside a solid tumor in the body. The energy converting materials are injected along with psoralen inside the solid tumor, then low dose x-ray energy is applied at the site. The energy converting materials convert the x-ray into UV light which activates the psoralen inside the solid tumor to kill the cancer.

"Transitioning into a clinical stage company represents a significant milestone in the company’s history and the potential beginning of a new era in cancer treatment," says Immunolight founder and CEO, Rick Bourke.

Currently in its 15th year of multidisciplinary research and development activities, Immunolight developed X-PACT in partnership with Duke University and Duke Medical Center with a team of over 30 scientists, physicians and engineers. "Our highest priority has been to translate this amazing science into a paradigm-changing cancer treatment in patients," Immunolight President Harold Walder says. "We are so excited to get this treatment into the clinic and potentially change patient’s lives and transform their treatment outcomes."

Harbour BioMed Reports 2021 Interim Results

On August 31, 2021 Harbour BioMed ("HBM", or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported its interim results for the six months ended June 30, 2021, and provided key business updates (Press release, Harbour BioMed, AUG 31, 2021, View Source [SID1234587073]).

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Corporate Highlights

Critical milestones of core clinical assets have been achieved: Batoclimab HBM9161 proceeds into full clinical stage development across the first group of indications with positive trial results reported, preparations being made for the second group of indications. Phase III trial of Tanfanercept HBM9036 are advancing at full speed. Significant progress has been made in HBM4003’s global development plan, and data readout of the clinical trial results will be released at ESMO (Free ESMO Whitepaper) (the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)) in September 2021.
Multiple research programs are developing at an accelerated pace, including: HBM7008, HBM9378, HBM1022, HBM1020, HBM7020, HBM7015, HBM1029 and HBM1007.
Scientific team has put forth a strong R&D contribution: within reporting period, the Company has applied for 28 patents with 4 patents issued including 1US and 3HK applications, while presenting research results at multiple medical and academic conferences.
Strengthened global partnerships continuously unlock value of HBM’s integrated antibody discovery platforms through entering into research cooperation agreement with the Dana-Farber Cancer Institute, Affiliated Hospital of Harvard Medical School; reaching a strategic collaboration agreement with BioMap, an AI driven research and development platform focusing on precision medicine; and further advancing academic cooperation with the Icahn School of Medicine at Mount Sinai.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented, "Harbour BioMed remains committed to developing innovative therapeutics for patients worldwide, becoming the leader in next generation antibody therapeutics with a strategic focus on immunology and oncology. In the first half of 2021, we further accelerated our product pipeline, advancing multiple clinical trials of the core products: Batoclimab and Tanfanercept are in preparation of expected commercial launches. We will continue to invest in HBM4003, and other numerous candidates generated from our discovery engine, while exploring innovative molecules with new targets as well as known targets. The remarkable business progress and growth momentum achieved in the first half of 2021 give us full confidence in securing the Company’s future. As such, the Company will continue to successfully navigate the complex market environment and provide innovative treatments for patients around the world."

Core clinical assets are advancing, further developing HBM’s product portfolio and pipeline

Since 2021, China’s healthcare reform has been further deepened, and reform of the pharmaceutical industry has gradually matured amidst policy and market changes. Adjustments made to the medical insurance catalog, price negotiation of medical insurance and a new round of volume procurement bring continuous challenges to drug pricing, especially pricing of products with weak differentiators. At the same time, the exploration of medical insurance reform has pushed the industry to pay more attention to drug pricing. The Company is committed to bringing benefits and value to patients, and value-based healthcare approach is adopted in its unique and differentiated portfolio planning as well as the clinical assets’ development.

Batoclimab HBM9161

A fully human monoclonal antibodies that can selectively bind to and inhibit the neonatal crystal fragment receptor (FcRn) and have the potential to treat a variety of autoimmune diseases. During the reporting period, the Company announced the positive results of its phase II clinical trial for Chinese patients with generalized myasthenia gravis (gMG), which is also the first clinical evidence of anti-FcRn therapy in Chinese patients. Batoclimab has entered full clinical stage development in:

Myasthenia Gravis (MG)

Obtained Breakthrough Therapy Designation (BTD) for MG treatment from China Center for Drug Evaluation (CDE) in January 2021.
Announced positive topline results from phase II clinical trial for MG in July 2021, as the first clinical evidence of anti-FcRn therapies among Chinese patients, which showed a statistically and clinically meaningful efficacy of Batoclimab over placebo, as well as a favorable safety and tolerability profile.
Held a "Phase II Ending" meeting with Center for Drug Evaluation, People’s Republic of China’s National Medical Products Administration (NMPA) and obtained their full support on proceeding to the phase III clinical trial.
The phase III study of MG will be initiated in the second half of 2021 and submission of a BLA application is expected to occur in 2022.
Neuromyelitis Optica Spectrum Disorder (NMOSD)

Completed the patient enrollment of NMOSD phase Ib/IIa clinical trials in July 2021.
Data analysis of phase Ib/IIa clinical trials is expected in the second half of 2021, and regulatory communication for key trials is anticipated at the end of 2021.
Expects to submit a BLA application in 2022.
Immune Thrombocytopenia (ITP)

Completed phase II clinical trials in the first half of 2021 and plans to conduct data analysis in the second half of 2021.
Obtained the NMPA’s approval for the new dosage regimen for ITP patients in February 2021.
Expects to submit a BLA application in 2023.
Graves Ophthalmopathy (GO)

Expects to initiate GO phase II/III registration trials in the second half of 2021 and submit a BLA application in 2023.
Other Indications

Submitted an IND application for chronic inflammatory demyelinating polyneuropathy (CIDP) indication to NMPA in May 2021.
Submitted an IND application for pemphigus vulgaris (PV) indication to NMPA in August 2021.
Tanfanercept HBM9036

Tanfanercept is the Company’s lead candidate product for the treatment of moderate to severe dry eye disease (DED), which is expected to meet the huge clinical needs of the Chinese patients.

Completed the first patient dosing in ongoing phase III clinical trial in China in March 2021.
Expects to submit a BLA application in 2022.
HBM4003

HBM4003 is a next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from HBM’s HCAb platform. It is also the world’s first fully human heavy chain only antibody to enter clinical development. In 2021, we have implemented the global development plan of multiple types of solid tumors utilizing HBM4003.

Obtained IND approvals of combination therapy with PD-1/chemotherapy for advanced non-small cell lung cancer (NSCLC) and other advanced solid tumors from NMPA in February 2021.
Achieved the first data readout of a phase I clinical trial of monotherapy in Australia with positive results. The abstract has been accepted by the ESMO (Free ESMO Whitepaper) and will be published at its annual conference in September 2021.
Accomplished the first dosing of part 2/dose expansion cohort of the phase I monotherapy clinical trial in May 2021.
Accomplished the first dosing in a phase I clinical trial for combination therapy with PD-1 for advanced melanoma and other advanced solid tumors in China in March 2021.
Accomplished the first dosing in a phase I clinical trial for combination therapy with PD-1/chemotherapy for advanced NSCLC and other advanced solid tumors in China in June 2021.
Submitted 2 IND applications for new indications, hepatocellular carcinoma (HCC) and neuroendocrine neoplasm (NEN), with PD-1 combination therapy in June 2021. We anticipate the approvals in the second half of 2021, and the Company plans to start patient dosing in early 2022.
Multiple potential preclinical assets approach clinical stage

In addition to the above-mentioned clinical assets, multiple potential products are also in full-speed preclinical development including: HBM7008, HBM9378, HBM1022, HBM1020, HBM7020, HBM7015, HBM1007, HBM1029, etc. – which are all approaching clinical stages. In the near future, the Company will continuously submit more IND applications through its efficient drug discovery engine.

HBM7008

HBM7008 is a bispecific antibody targeting Tumor Associated Antigen (B7H4)x4-1BB. It is discovered from Company’s heavy-chain antibody immune cell engager HBICE and is currently the only bispecific antibody against these two targets worldwide. It is expected to file a CTA/IRB submission in the second half of 2021.

HBM9378

HBM9378 is a fully human monoclonal antibody generated from HBM’s H2L2 platform, which has less immunogenicity risk and better bioavailability comparing to the other TSLP target competitors. The long half-life optimization and outstanding biophysical properties support its favorable dosing and formulation advantages. It is expected that an IND application will be submitted in the second half of 2021.

HBM1022

HBM1022 is a CCR8 antibody developed by HBM, which cross-reacts with the CCR8 target of cynomolgus monkeys, and has demonstrated its significant tumor growth inhibitory effect in mouse tumor models. As an innovative target, CCR8-targeted drugs have not yet entered the clinical development stage globally. It is expected that an IND application will be submitted in 2022.

HBM1020

HBM1020 is a fully human monoclonal antibody generated from HBM’s H2L2 platform. The antibody is directed against a brand-new target in the B7 family and can enhance the anti-tumor immunity by blocking the immune checkpoint target. Preclinical data has demonstrated its immune activation and anti-tumor functional activities. It is expected to file an IND in 2022.

HBM1007

HBM1007 is a fully human monoclonal antibody against CD73 generated from HBM’s H2L2 platform. It is an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. HBM1007 is being studied in preclinical setting and an IND application is expected to be submitted in 2022.

HBM7020, HBM1029 and HBM7015

HBM7020 is a BCMAxCD3 bispecific antibody equipped with HBM’s HBICE technology. HBM1029 is a fully human monoclonal antibody developed from the Company’s H2L2 platform with higher CLDN18.2 binding affinity and stronger ADCC and CDC anti-tumor activities. HBM7015 is a bifunctional fusion protein generated from the H2L2 platform that demonstrated better PD-L1 binding activity than competitor drugs.

In 2020, the Company licensed-out the Greater China rights and interests of three preclinical products (HBM7020, HBM1029 and HBM7015) developed from its own technology platform to Hualan Genetic, a Chinese biopharmaceutical corporation. After completing the technology transfer, the two companies have jointly worked on the development of these three innovative products. It is expected that IND applications for these products will be submitted in 2022.

Build a global innovation hub with strong R&D capabilities and expertise

HBM focuses on a new generation of innovative therapies in the field of immunology and oncology. The drug discovery and preclinical research team has conducted drug discovery, formulation development, process development and preclinical research on new drug candidates. At the same time, the Company has a professional team of scientists to optimize, upgrade and re-develop our technology platform.

During the reporting period, the Company’s main progress in drug discovery, technology platform and patents are as follows:

Applied for 28 patents, 4 patents got issued including 1 US and 3 HK applications. These patent applications have further strengthened the intellectual property protection of the Company’s core products and technology platforms.
Developed and presented a newly discovered fully human anti-B7H7 monoclonal antibody HBM1020 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021.
Developed and presented a novel bispecific antibody HBM7022 (CLDN18.2xCD3) at the Antibody Engineering and Therapeutics (AET) Conference in June 2021.
HBM has established a robust antibody discovery platform and GPCR drug development platform. Based on these technology platforms, the Company is expected to move towards more novel and challenging drug targets worldwide.

Strengthened R&D collaborations worldwide

During the reporting period, HBM continued to expand collaborations with leading global academic institutions and selected industry partners focused on innovation and efficiency. HBM’s flexible business models built around our proprietary technologies and our strong internal discovery capabilities can and will maximize our platform value by leveraging complementary advantages from the Company and our collaborators.

In May 2021, it reached a strategic cooperation agreement with BioMap, committed to the scientific research, development and transformation of new antibodies products, and integrated BioMap’s artificial intelligence technology advantages into the Harbour Mice platform.
In June 2021, it entered into a multi-year and multifaceted research cooperation agreement with Dana-Farber Cancer Institute ("Dana-Farber"), an affiliated hospital of Harvard Medical School, to jointly develop new biological therapies in cancer treatment. Company scientists and Dana-Farber researchers will jointly develop novel biotherapies in cancer treatment, including bispecific antibodies, CAR-T cell products, etc.
Further advanced academic cooperation with Icahn School of Medicine at Mount Sinai ("Mount Sinai") in connection with an exclusive license agreement between Mount Sinai and a third party over a collection of antibodies having SARS-CoV-2 (COVID-19) neutralizing assets generated from Harbour Mice platform.
Build internal manufacturing and commercialization capability to support clinical development and product launches

With the maturity of our pre-clinical products, we planned to build internal manufacturing and commercialization capability in due course.

In 2021, the Company initiated the clinical supply manufacturing facility project to support the clinical development of its pipeline products. The pilot facility is located in Suzhou, Jiangsu Province. The facility’s floor area is of around 8,500 square meters and the designed production capability scales up to 4000 liters. With the initiation and rapid formation of the Company’s CMC team, it is expected that the facility will be ready for manufacturing in 2022.
The Company has begun to build a commercial team with in-depth knowledge, experience and expertise in sales, marketing, and market access strategies, who will be involved in launches across several therapeutic areas. During the reporting period, the commercial team has initiated preparation for the launch of leading products, future academic promotion and pipeline expansion.
Financial Summary of First Half of 2021

For the half-year ended June 30, 2021, the Company recorded a revenue of US$2.2 million, mainly from molecule license fee.

For the half-year ended June 30, 2021, the Company’s other income and gains were US$2.7 million, mainly attributable to the increase of bank deposit interest, as well as increase of government subsidy and grants.

For the half-year ended June 30, 2021, the Company’s R&D expenses were US$41.2 million, increased investment in key clinical programs, discovery and pre-clinical programs; increased employee costs, mainly research scientists and development clinician headcounts, as well as share-based compensation expenses.

About HBM4003

HBM4003 is the next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from Harbour Mice. It is the first molecule generated through our in-house efforts and has entered clinical trial since first being discovered as a drug candidate only 3 years ago. HBM4003 is the world’s first fully human heavy chain only anti CTLA-4 antibody entered into clinical development. It shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

About Tanfanercept (HBM9036)

Tanfanercept (HBM9036) is at the forefront of the Company’s R&D pipeline, it is a modified 19 kDa TNF receptor 1 fragment and is for the treatment of moderate to severe Dry Eye Disease. Tanfanercept has the potential to seize a majority market share in a fast-growing DED drug market.

About Batoclimab (HBM9161)

Batoclimab (HBM9161) is a novel, fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn). As the first in class FcRn inhibitor being developed in Greater China, it is expected to become a breakthrough therapy to patients with autoimmune disease conditions.

Medivir receives regulatory approval from MHRA for phase 1/2a combination study with MIV-818

On August 31, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that the company has received regulatory approval from the British Medicines & Healthcare products Regulatory Agency (MHRA) for its upcoming phase 1/2a combination study with the company’s leading candidate drug MIV-818 against liver cancer (Press release, Medivir, AUG 31, 2021, View Source [SID1234587072]). In the study, MIV-818 will be administered in two combinations, either with lenvatinib, a tyrosine kinase inhibitor or pembrolizumab, an anti-PD-1 check-point inhibitor.

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The planned trial will be an open-label, multi-center phase 1/2a study starting with a dose escalation part to establish the recommended phase 2 dose (RP2D). This is followed by the expansion study (phase 2a) with an initial evaluation of the safety and efficacy of the combination of MIV-818 with lenvatinib or pembrolizumab. The study will include patients with hepatocellular carcinoma (HCC) who have progressed on, or are intolerant of, first line standard therapy.

The study is planned to have two parallel dose-escalation streams. Once the RP2D has been established for the combinations, further cohorts of up to 30 patients with HCC will be enrolled in the phase 2a part of the study. The study will start in the UK and is planned later to include centers in Spain and South Korea. The first patient is expected to be enrolled in the second half of 2021.

"It is satisfactory that the preparations for the study are progressing according to plan. The MHRA approval is also an important seal of quality in the planning and design of the study," said Magnus Christensen, Interim CEO of Medivir.

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC is now planned to be initiated during the second half of 2021.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

Striving to Deliver Better Outcomes: Janssen to Showcase Commitment to Advancing Science for Genitourinary Cancers at AUA 2021

On August 31, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported multiple company-sponsored presentations in prostate and bladder cancers will be highlighted at the virtual 2021 American Urological Association Annual Meeting (AUA 2021), September 10-13 (Press release, Johnson & Johnson, AUG 31, 2021, View Source [SID1234587069]).

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"Janssen maintains a strong commitment to advancing innovation and new therapeutic options for patients with genitourinary malignancies. As the treatment of genitourinary cancers becomes more complex, we continue to work with urologists and their teams to improve outcomes for patients across the continuum of disease," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. "We look forward to sharing the latest results from across our pipeline and portfolio at the upcoming AUA meeting and remain focused on accelerating science that unlocks new opportunities along the care pathway, from diagnosis to treatment of advanced disease."

Janssen will share four data presentations highlighting clinical advances for two therapies from our solid tumor portfolio.

ERLEADA studies to be presented at AUA include:

Real-World Effectiveness and Treatment Adherence in Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) Patients (oral presentation): Real-world evidence from 63 urology practices across the U.S. detailing prostate-specific antigen (PSA) outcomes and treatment adherence among patients with nmCRPC treated with ERLEADA, with stratification by race (Abstract #PD05-08)
Prostate-Specific Antigen Kinetics in Patients from TITAN and SPARTAN (oral presentation): Post-hoc analysis of PSA kinetics in 1,331 patients treated with ERLEADA from both the TITAN and SPARTAN trials (Abstract #PD34-11)
Sites and Burden of Metastases and Long-Term Outcomes in TITAN Patients (moderated poster session): Assessment of relationships between the number and location of metastases and oncological outcomes in 1,052 patients with metastatic castration-sensitive prostate cancer (mCSPC) enrolled in the TITAN trial (Abstract #MP24-08)
Additionally, Janssen will present an update on the Phase 3 SunRISe-2 trial evaluating an investigational intravesical drug delivery system, TAR-200, in combination with the programmed cell death receptor-1 (PD-1) inhibitor cetrelimab in muscle-invasive urothelial carcinoma (Abstract # MP13-17).1

"As part of our commitment to help patients live longer and better lives, Janssen looks forward to expanding the focus from our legacy in prostate cancer to include other genitourinary cancers," said Serge Messerlian, President, Oncology, Janssen Biotech, Inc. "We’re collaborating with diverse urology stakeholders to understand and meet the challenges along the path to better care, leveraging clinical and operational excellence to strengthen our allyship with the entire urology community."

Further details about these data and the ways Janssen is working to shape the future of urologic care will be made available throughout AUA 2021 via the Janssen AUA Virtual Newsroom.

Abstracts to be presented at the meeting include:

Abstract No.

Title

Date/Time

ERLEADA (apalutamide)

Podium Presentations

Abstract #
PD05-08

Real-World Effectiveness and Treatment
Adherence of Apalutamide in Non-Metastatic
Castration-Resistant Prostate Cancer Patients

Friday,

September 10

8:10 AM – 8:20 AM
PST

Abstract #
PD34-11

Prostate-Specific Antigen Kinetics in Patients
with Advanced Prostate Cancer Treated with
Apalutamide: Results from the TITAN and
SPARTAN Studies

Saturday,

September 11

5:10 PM – 5:20 PM
PST

Moderated Poster

Abstract #
MP24-08

Relationships of Sites and Burden of
Metastases with Long-Term Outcomes and
Molecular Subtypes in TITAN

Saturday,

September 11

8:45 AM – 10:00
AM PST

TAR-200

Poster Presentation

Abstract #
MP13-17

SunRISe-2: A Phase 3, Multicenter,
Randomized Study Evaluating the Efficacy of
TAR-200 in Combination with Cetrelimab
Versus Concurrent Chemoradiotherapy in
Participants with Muscle-Invasive Urothelial
Carcinoma of the Bladder

Friday,

September 10

2:45 PM – 4:00 PM
PST

About ERLEADA
ERLEADA (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).2 ERLEADA received U.S. FDA approval for nmCRPC in February 2018, and was approved for mCSPC in September 2019.2 To date, more than 40,000 patients worldwide have been treated with ERLEADA.

For more information, visit www.ERLEADA.com.

About TAR-200
TAR-200 is an investigational drug delivery system, enabling controlled release of gemcitabine into the bladder, increasing dwell time and local drug exposure. The safety and efficacy of TAR-200 is being evaluated in Phase 3 studies in patients with muscle-invasive bladder cancer (MIBC).

About Cetrelimab
Cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied to treat MIBC, prostate cancer and multiple myeloma as a combination treatment.

ERLEADA IMPORTANT SAFETY INFORMATION 2
WARNINGS AND PRECAUTIONS

Cerebrovascular and Ischemic Cardiovascular Events — In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA and 3% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA and 2% of patients treated with placebo. Across the SPARTAN and TITAN studies, 5 patients (0.5%) treated with ERLEADA and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. Patients with history of unstable angina, myocardial infarction, congestive heart failure, stroke, or transient ischemic attack within 6 months of randomization were excluded from the SPARTAN and TITAN studies.

In the SPARTAN study, cerebrovascular events occurred in 4.7% of patients treated with ERLEADA and 0.8% of patients treated with placebo. In the TITAN study, cerebrovascular events occurred in 1.9% of patients treated with ERLEADA and 2.1% of patients treated with placebo. Across the SPARTAN and TITAN studies, 3 patients (0.2%) treated with ERLEADA, and 2 patients (0.2%) treated with placebo died from a cerebrovascular event.

Cerebrovascular and ischemic cardiovascular events, including events leading to death, occurred in patients receiving ERLEADA. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA for Grade 3 and 4 events.

Fractures — In a randomized study (SPARTAN) of patients with nmCRPC, fractures occurred in 12% of patients treated with ERLEADA and in 7% of patients treated with placebo. In a randomized study (TITAN) of patients with mCSPC, fractures occurred in 9% of patients treated with ERLEADA and in 6% of patients treated with placebo. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

Falls — In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA compared with 9% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Falls occurred in patients receiving ERLEADA with increased frequency in the elderly. Evaluate patients for fall risk.

Seizure — In 2 randomized studies (SPARTAN and TITAN), 5 patients (0.4%) treated with ERLEADA and 1 patient treated with placebo (0.1%) experienced a seizure. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA. Advise patients of the risk of developing a seizure while receiving ERLEADA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.

Embryo-Fetal Toxicity — The safety and efficacy of ERLEADA have not been established in females. Based on its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1, 8.3)].

ADVERSE REACTIONS
Adverse Reactions — The most common adverse reactions (≥10%) that occurred more frequently in the ERLEADA-treated patients (≥ 2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea and fracture.

Laboratory Abnormalities — All Grades (Grade 3-4)

Hematology — In the TITAN study: white blood cell decreased ERLEADA 27% (0.4%), placebo 19% (0.6%). In the SPARTAN study: anemia ERLEADA 70% (0.4%), placebo 64% (0.5%); leukopenia ERLEADA 47% (0.3%), placebo 29% (0%); lymphopenia ERLEADA 41% (2%), placebo 21% (2%)
Chemistry — In the TITAN study: hypertriglyceridemia ERLEADA 17% (3%), placebo 12% (2%). In the SPARTAN study: hypercholesterolemia ERLEADA 76% (0.1%), placebo 46% (0%); hyperglycemia ERLEADA 70% (2%), placebo 59% (1%); hypertriglyceridemia ERLEADA 67% (2%), placebo 49% (0.8%); hyperkalemia ERLEADA 32% (2%), placebo 22% (0.5%)
Rash — In 2 randomized studies, rash was most commonly described as macular or maculopapular. Adverse reactions of rash were 26% with ERLEADA vs 8% with placebo. Grade 3 rashes (defined as covering >30% body surface area [BSA]) were reported with ERLEADA treatment (6%) vs placebo (0.5%).

The onset of rash occurred at a median of 83 days. Rash resolved in 78% of patients within a median of 78 days from onset of rash. Rash was commonly managed with oral antihistamines, topical corticosteroids, and 19% of patients received systemic corticosteroids. Dose reduction or dose interruption occurred in 14% and 28% of patients, respectively. Of the patients who had dose interruption, 59% experienced recurrence of rash upon reintroduction of ERLEADA.

Hypothyroidism — In 2 randomized studies (SPARTAN and TITAN), hypothyroidism was reported for 8% of patients treated with ERLEADA and 2% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA and 7% of patients treated with placebo. The median onset was at the first scheduled assessment. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted.

DRUG INTERACTIONS

Effect of Other Drugs on ERLEADA — Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties. No initial dose adjustment is necessary; however, reduce the ERLEADA dose based on tolerability [see Dosage and Administration (2.2)].

Effect of ERLEADA on Other Drugs
CYP3A4, CYP2C9, CYP2C19, and UGT Substrates — ERLEADA is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. Concomitant use of ERLEADA with medications that are primarily metabolized by CYP3A4, CYP2C19, or CYP2C9 can result in lower exposure to these medications. Substitution for these medications is recommended when possible or evaluate for loss of activity if medication is continued. Concomitant administration of ERLEADA with medications that are substrates of UDP-glucuronosyl transferase (UGT) can result in decreased exposure. Use caution if substrates of UGT must be co-administered with ERLEADA and evaluate for loss of activity.

P-gp, BCRP or OATP1B1 Substrates — Apalutamide is a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically. Concomitant use of ERLEADA with medications that are substrates of P-gp, BCRP, or OATP1B1 can result in lower exposure of these medications. Use caution if substrates of P-gp, BCRP or OATP1B1 must be co-administered with ERLEADA and evaluate for loss of activity if medication is continued.

Please see the full Prescribing Information for ERLEADA.