On March 16, 2023 Aflac Incorporated reported that the company has released its 2022 Business and Sustainability Report, titled "The Aflac Way: Making a Difference While Balancing Purpose and Profit" (Press release, Aflac, MAR 16, 2023, View Source [SID1234628956]). The 2022 Business and Sustainability report is available at investors.aflac.com under "Sustainability."

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The 2022 Business and Sustainability Report provides key insights into how Aflac Incorporated focuses on the Company’s long tradition of doing what is right for its employees and communities and an overview of operations and financial results for the 2022 fiscal year. This year’s report also highlights achievements of the company advancing integration of responsible investing into its investment and ownership decisions; progressing on its path to net zero emissions; committing $741 million in 2022 to sustainable and DEI investments; completely allocating the net proceeds from the $400 million sustainability bond issued by Aflac Incorporated on March 8, 2021; continuing to foster an inclusive culture in Japan and the U.S.; exceeding $165 million in contributions in support of the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta; supporting 149,000 pediatric patients and their families who stay at the Aflac Parents House in Japan during treatments; and giving a My Special Aflac Duck to more than 21,000 children since 2018 to provide comfort through their treatment for cancer and most recently, sickle cell disease. It also highlights Aflac Incorporated’s focus on strong governance and commitment to being a good steward of the environment.

About the 2022 Business and Sustainability Report, Aflac Incorporated Chairman and CEO Dan Amos commented: "Let’s be clear: profits and shareholder returns determine whether a company is successful, but we have always been a company that has viewed giving back to our community as the right thing to do. This has become a part of our culture and reflected in how we operate, what we refer to as "The Aflac Way," for as long as I can remember. I’m proud of what we have accomplished by delivering solid results while focused on our social purpose. Today, customers, investors and other stakeholders want to know about a company’s purpose before making decisions. We’ve always given back, but now it is also important to proactively share information, as we do in this report about how we balance purpose and profit."

Aflac Incorporated President and Chief Operating Officer Frederick J. Crawford added: "We believe that sustainability and financial performance must be pursued in a way that naturally coexists and serves to enhance our overall franchise value. Simply put, we focus on diversity, environment and social commitments to attract the best talent and connect with the communities we serve in a way that supports our brand and the expectations of our distribution partners and policyholders. In turn, we perform better, which attracts capital to our company, such that we can continue to grow. In the spirit of the transparency we prioritize, we’ve posted material that our investors have expressed an interest in seeing,"

The report also integrates various reporting frameworks, including the Sustainability Accounting Standards Board (SASB), the Task Force on Climate-related Financial Disclosures (TCFD), United Nations Sustainable Development Goals (SDGs) and the Global Reporting Initiative (GRI), which are easily located in the report’s ESG Reporting Index.

Investors may learn more about how Aflac Incorporated balances purpose and profit at investors.aflac.com under "Sustainability" including the company’s most recent TCFD Report, the Aflac U.S. 2021 EEO-1 Disclosure and the company’s Carbon Disclosure Project (CDP) submission.

On March 16, 2023 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported that the Company has been granted a formal extension to regain compliance under Nasdaq Listing Rule 5550(b)(2) or its alternative criteria (Press release, TC Biopharm, MAR 16, 2023, View Source [SID1234628955]). The Company is obligated to meet certain milestones, but has until June 30, 2023 to meet the requirement.

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The extension was granted following TC BioPharm’s presentation of a formal plan to the Nasdaq Hearings Panel on Thursday, March 9, 2023. As part of the extension, the Company is obligated to meet certain interim milestone requirements. Nasdaq Listing Rule 5550(b)(2) (the "MVLS Requirement") states that a company must possess the minimum Market Value of $35,000,000 required for continued listing on The Nasdaq Capital Market or the alternative criteria of $2,500,000 in shareholders’ equity or $500,000 in net income from continued operations. The Company is working to implement a plan to demonstrate compliance.

Nasdaq’s extension notice has no immediate effect on the listing or trading of TC BioPharm’s Common Stock, which will continue to trade on the Nasdaq Capital Market under the symbol "TCBP".

On March 16, 2023 Akumin Inc. (NASDAQ: AKU) (TSX: AKU) ("Akumin" or the "Company"), a national partner of choice for U.S. hospitals, health systems and physician groups, with comprehensive solutions addressing outsourced radiology and oncology service-line needs, reported its financial results for the quarter and year ended December 31, 2022 (Press release, Akumin, MAR 16, 2023, View Source [SID1234628954]).

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Fourth Quarter 2022 Highlights

Akumin delivered fourth quarter same-store volume performance on a consolidated, pro forma basis as follows:
-0.3% for MRI
+7.8% for PET/CT
+8.0% for Oncology Patient Starts
The Company reported revenue totaling $184.6 million for the fourth quarter, a $5.2 million or 3% increase over the fourth quarter of last year. For the full year ended December 31, 2022, Akumin reported revenue of $749.6 million, a $328.6 million or 78% increase over the full year 2021. This year-over-year increase was primarily as a result of the Alliance HealthCare Services acquisition (the "Alliance Acquisition") which was completed on September 1, 2021.
Net loss was $49.3 million and $151.6 million for the fourth quarter and year ended December 31, 2022, respectively, an increase in net loss of $22.7 million and $116.8 million, respectively, compared to the prior periods primarily due to higher interest expense, goodwill impairment charges, restructuring charges, and severance and related costs, partially offset by lower acquisition-related costs.
Akumin generated $37.4 million of Adjusted EBITDA* (as defined below) for the fourth quarter, a $9.9 million or 36% increase over the fourth quarter of last year. For the full year ended December 31, 2022, Akumin reported Adjusted EBITDA* of $144.1 million, a $77.2 million or 115% increase over the full year 2021, primarily as a result of the Alliance Acquisition.
*For a reconciliation of Adjusted EBITDA, which is a non-GAAP measure, to the most directly comparable GAAP financial measure, please see "Reconciliation of Non-GAAP Financial Measures".

Summary Consolidated Financial Results (in thousands, except for per share amounts)

3-month period
ended

Dec 31, 2022

3-month period
ended

Dec 31, 2021

Year ended

Dec 31, 2022

Year ended

Dec 31, 2021

MRI Scans

217

217

876

539

PET-CT Scans

34

32

133

46

Oncology Patient Starts

2.623

2.504

10.347

3.401

Revenue

$184,635

$179,443

$749,631

$421,079

Net Loss

($49,331)

($26,632)

($151,587)

($34,814)

Adjusted EBITDA (1)

$37,381

$27,522

$144,102

$66,903

EPS –Diluted

$(0.46)

$(0.36)

$(1.75)

$(0.56)

(1) See "Non-GAAP Measures" below.

Commenting on the year-end results, Riadh Zine, Chairman and Chief Executive Officer of the Company, said, "We are pleased that we were able to deliver strong financial results, within our updated guidance range for the quarter and full year. Our results are particularly impressive given that 2022 was a transformational year for Akumin, during which we successfully integrated our $786 million acquisition of Alliance HealthCare Services. The integration comprised a number of initiatives including the implementation of a restructuring resulting in excess of $20 million of organizational savings in our first phase of transformation efforts, consolidation of underperforming sites, and completion of a comprehensive review and repositioning of our oncology business.

"We also had to respond to several industry-wide challenges, including a shortage of clinical labor which negatively impacted our ability to generate same-store revenue growth, and unprecedented cost inflation, particularly in the areas of labor, third-party services, and medical supplies. Despite these challenges, we were able to deliver solid performance and have positioned the business for strong organic growth in 2023 and beyond.

"Our transformation initiatives are well underway and, as we stated in the third quarter, we believe both the second and third phases of our transformation efforts, which are focused on asset rationalization, network integration, and purchasing power, are expected to result in more than $25 million in additional run-rate synergies during 2023, Zine continued.

"Akumin’s vision is to be the partner of choice for health systems and hospitals by leveraging our dense network coverage to serve patients in their community, implementing best-in-class clinical standardization to improve patient care, and deploying technology to achieve operational excellence to enhance the patient experience," Mr. Zine concluded.

Full-Year 2023 Financial Outlook

Akumin is also pleased to announce today its full year ending December 31, 2023 financial outlook. Akumin currently expects that the financial results of the Company for 2023 will be as follows:

Akumin Full-Year 2023 Guidance (1)

Revenue

$765-775mm

Adjusted EBITDA (2)

$150-160mm

Capex

$55-65mm

(1) For additional information on forward-looking statements, see the section titled "Forward-Looking Information" below.

(2) See "Non-GAAP Measures" below.

Commenting on the 2023 financial outlook, Zine said, "While we have begun to see some improvement to the operating conditions we faced in 2022, some ongoing labor constraints and cost inflation persist in some of our markets which we have factored in to our outlook for 2023, notwithstanding the strong demand for our services which we expect to continue. We are confident in our ability to deliver solid results in 2023 and are encouraged by these early developments thus far in the year."

Unless otherwise indicated, all amounts are expressed in U.S. dollars. Certain metrics, including those expressed on an adjusted or comparable basis, are non-GAAP measures. See "Non-GAAP Measures" and "Selected Consolidated Financial Information" of this press release for further details.

Investor Presentation

Akumin would like to invite interested parties to an investor presentation to be held on Friday, March 17, 2023 from 8:30 a.m. to 9:30 a.m. Eastern Time where management will discuss fourth quarter and year-end results.

Conference call details:

Date:

8:30 a.m. Eastern Time, Friday, March 17, 2023

Click to join by phone:

View Source

Access via webcast:

View Source

A related presentation will be available from Akumin’s website (www.akumin.com) and at View Source Participants are asked to connect at least 10 minutes prior to the beginning of the call to ensure participation. The webcast archive will be available for 90 days. A replay of the presentation will also be available by calling 1-888-203-1112, or 647-436-0148 for international callers, using passcode 6212460.

On March 16, 2023 Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported positive topline results from the Phase 3 EMBARK trial evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) (Press release, Pfizer, MAR 16, 2023, View Source [SID1234628953]). Patients enrolled in the trial were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide.

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At the time of the analysis, a positive trend in the key secondary endpoint of overall survival (OS) was also observed, but these data were not yet mature. Patients in the trial will be followed for a subsequent final OS analysis. The study also met a key secondary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI monotherapy versus placebo plus leuprolide. Additional key secondary endpoints reached statistical significance, including time to prostate-specific antigen (PSA) progression and time to first use of new antineoplastic therapy. Other secondary endpoints are being analyzed. No new safety signals have been observed to date in the preliminary safety analysis, which is consistent with the established safety profile of XTANDI.

"As the only novel hormone therapy approved for three disease states of prostate cancer in the U.S., XTANDI has impacted hundreds of thousands of men," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. "The topline findings from EMBARK are highly encouraging and we look forward to engaging with health authorities to potentially bring XTANDI to men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence."

"While current treatment options for localized prostate cancer are intended to be curative, some men remain at higher risk for biochemical recurrence following primary treatment, which may result in metastases," said Ahsan Arozullah, M.D., MPH, Senior Vice President and Head of Development Therapeutic Areas, Astellas. "The EMBARK trial is the first study to demonstrate a statistically significant improvement in MFS using the combination of XTANDI plus leuprolide in men with this stage of disease."

Detailed results from EMBARK will be presented at a future medical meeting. These data will also be discussed with regulatory authorities, including the U.S. Food and Drug Administration (FDA), to support a potential regulatory submission for XTANDI in this indication.

About EMBARK
The Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) at sites in the United States, Canada, Europe, South America, and the Asia-Pacific region. Patients who were considered high-risk BCR had a prostate-specific antigen (PSA) doubling time ≤ 9 months, serum testosterone ≥ 150 ng/dL (5.2 nmol/L), and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide, enzalutamide 160 mg as a monotherapy, or placebo plus leuprolide.

The primary endpoint of the trial was metastasis-free survival (MFS) for enzalutamide plus leuprolide and placebo plus leuprolide. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death. For more information on the EMBARK (NCT02319837) trial go to www.clinicaltrials.gov.

XTANDI has not been approved for the treatment of patients with nmHSPC with high-risk BCR.

About Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
Non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) means there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) with conventional radiological methods (CT/MRI) and the cancer still responds to medical or surgical treatment to lower testosterone levels.1,2 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years.3 About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of the recurrence.3 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC with high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA doubling time ≤ 9 months. High-risk BCR patients with a PSA doubling time of ≤ 9 months have a higher risk of metastases and death.4

About XTANDI (enzalutamide)
XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. The recommended dosage of XTANDI is 160 mg (capsules or tablets) administered orally once daily with or without food. XTANDI is a standard of care that has received regulatory approvals for use in men with mHSPC, mCRPC, and nmCRPC in the United States and for one or more of these indications in more than 100 countries, including the European Union and Japan. More than 720,000 patients have been treated with XTANDI globally.5

E.U. Important Safety Information
Enzalutamide is indicated in the European Union for the treatment of adult men with:

1. Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
2. High-risk non-metastatic castration-resistant prostate cancer (CRPC).
3. Metastatic CRPC who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated. It is also indicated in adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

For Important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: View Source

U.S. Important Safety Information
XTANDI (enzalutamide) is indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space-occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in seven randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of four randomized, placebo-controlled clinical studies, falls occurred in 11% of patients treated with XTANDI compared to 4% of patients treated with placebo. Fractures occurred in 10% of patients treated with XTANDI and in 4% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI 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 with XTANDI and for 3 months after the last dose of XTANDI.

Adverse Reactions (ARs) In the data from the four randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to adverse events (AEs) were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to AEs were reported for 6% of XTANDI treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AE as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.

In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher AEs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to AEs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia.

Hypertension: In the combined data from four randomized placebo-controlled clinical trials, hypertension was reported in 12% of XTANDI patients and 5% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If coadministration is necessary, increase the dose of XTANDI. Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

Please see Full Prescribing Information for additional safety information.

On March 16, 2023 Novartis reported the U.S. Food and Drug Administration (FDA) granted approval for Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (Press release, Novartis, MAR 16, 2023, https://www.novartis.com/news/media-releases/novartis-tafinlar-mekinist-approved-fda-pediatric-patients-braf-v600e-low-grade-glioma-most-common-pediatric-brain-cancer [SID1234628952]). The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age. These approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG.

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"Pediatric cancer research is vital to uncover new treatment methods for a population," said Dr. Eric Bouffet, MD, FRCPC, Principal Investigator of the TADPOLE clinical trial and Associate Scientist Emeritus at The Hospital for Sick Children (SickKids). "Developing targeted therapies based on the unique genetic features of a patient’s tumor is the future of pediatric cancer care."

This FDA approval of Tafinlar + Mekinist is based on results from the Phase II/III TADPOLE trial (NCT02684058) that showed patients randomized to receive Tafinlar + Mekinist experienced a statistically significant improvement in overall response rate (ORR) of 47% (CI: 35-59%) compared to 11% (CI: 3-25%) for those randomized to receive chemotherapy. At a median follow-up of 18.9 months, median progression-free survival (PFS) was 20.1 months with Tafinlar + Mekinist (CI: 12.8 months-not estimable) compared to 7.4 months with chemotherapy (CI: 3.6-11.8 months, hazard ratio=0.31 [CI: 0.17-0.55] [p<0.001]).

"It is more important than ever to test for genetic mutations in patients living with low-grade glioma. This FDA approval may offer new hope to pediatric patients living with BRAF V600E low-grade glioma," said Dr. Roger Packer, senior vice president of the Center for Neurosciences and Behavioral Medicine at Children’s National Hospital. "This has the potential to change the way healthcare providers treat these pediatric patients, offering a significant advancement compared to chemotherapy."

The safety profile of Tafinlar + Mekinist observed in this study was consistent with the known safety profile in other approved indications. The most common adverse reactions (>=15%) were pyrexia (68%), rash (51%), headache (47%), vomiting (34%), musculoskeletal pain (34%), fatigue (33%), diarrhea (29%), dry skin (26%), nausea (25%), hemorrhage (25%), abdominal pain (25%), dermatitis acneiform (22%), dizziness (15%), upper respiratory tract infection (15%) and weight increased (15%). These data were highlighted as part of an official press briefing and oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"This new indication for Tafinlar + Mekinist is a potential new standard of care treatment option for young patients with this form of brain cancer with a BRAF V600E mutation, in formulations specifically designed for them," said Reshema Kemps-Polanco, Executive Vice President, US Oncology at Novartis. "We are thankful for the families, including children and adolescents, that participated in the clinical trial that led to this approval and whose bravery has led to a new hope for children living with this serious brain cancer."

LGG is the most common pediatric brain cancer. BRAF V600 mutations are present in 15-20% of pediatric LGGs and are associated with poor survival outcomes and less favorable response to chemotherapy4. BRAF mutations have been identified as drivers of cancer growth across a wide range of solid tumors, and often have limited treatment options4,5.

Full prescribing information for Tafinlar + Mekinist can be found at View Source and View Source

About Tafinlar + Mekinist
The combination of Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition research and patients reached, may help to slow tumor growth by blocking signals associated with the BRAF and MEK kinases that are implicated in the growth of various types of cancer1,2,4,5. Tafinlar + Mekinist has been studied in more than 6,000 BRAF-positive patients in more than 20 ongoing and completed trials, including in pediatric patients 1 year of age and older, and has been prescribed to more than 200,000 patients worldwide6.

This FDA approval is the sixth for Tafinlar + Mekinist, which is indicated across multiple BRAF V600 solid tumors, including melanoma, thyroid cancer and lung cancer1,2.

Indication and Important Safety Information
TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma:

that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and
that has a certain type of abnormal "BRAF" (V600E or V600K mutation-positive) gene
TAFINLAR and MEKINIST are prescription medicines that can be used in combination to help prevent melanoma that has a certain type of abnormal "BRAF" gene from coming back after the cancer has been removed by surgery.

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic NSCLC), and that has a certain type of abnormal "BRAF V600E" gene.

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC):

that has spread to other parts of the body and you have no satisfactory treatment options and
that has a certain type of abnormal "BRAF" gene
TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat solid tumors in adults and children 6 years of age and older:

that cannot be removed by surgery or have spread to other parts of the body, and that have gotten worse (progressed) and you have no satisfactory treatment options and
that have a certain type of abnormal "BRAF" gene
The effectiveness of TAFINLAR and MEKINIST in these patients is based on 2 adult studies and 1 pediatric study that measured 2 types of response to treatment (response rate and duration of response). No clinical information is available to show if these patients treated with TAFINLAR and MEKINIST live longer or if their symptoms improve. Ongoing studies exist to determine how TAFINLAR and MEKINIST works over a longer period.

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat a type of brain tumor called glioma in children 1 year of age and older

that is low-grade glioma (LGG), and
that have a certain type of abnormal "BRAF" gene, and
who require a medicine by mouth or injection (systemic therapy)

TAFINLAR, in combination with MEKINIST, is not for use in treating people with colorectal cancer or wild-type BRAF solid tumors. MEKINIST should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma and it did not work or is no longer working.

Your health care provider will perform a test to make sure that TAFINLAR and MEKINIST, in combination, are right for you.

It is not known if TAFINLAR used in combination with MEKINIST is safe and effective in children younger than 6 years of age.

TAFINLAR and MEKINIST, in combination, may cause serious side effects such as the risk of new cancers, including both skin cancer and nonskin cancer. Patients should be advised to contact their health care provider immediately for any skin changes, including a new wart, skin sore, or bump that bleeds or does not heal, or a change in the size or color of a mole.

When TAFINLAR is used in combination with MEKINIST, it can cause serious bleeding problems, especially in the brain or stomach, that can lead to death. Patients should be advised to call their health care provider and get medical help right away if they have any signs of bleeding, including headaches, dizziness, or feeling weak, coughing up blood or blood clots, vomiting blood or their vomit looks like "coffee grounds," or red or black stools that look like tar.

MEKINIST, alone or in combination with TAFINLAR, can cause inflammation of the intestines or tears in the stomach or intestines that can lead to death. Patients should report to their health care provider right away if they have any of the following symptoms: bleeding, diarrhea (loose stools) or more bowel movements than usual, stomach-area (abdomen) pain or tenderness, fever, or nausea.

TAFINLAR, in combination with MEKINIST, can cause blood clots in the arms or legs, which can travel to the lungs and can lead to death. Patients should be advised to get medical help right away if they have the following symptoms: chest pain, sudden shortness of breath or trouble breathing, pain in their legs with or without swelling, swelling in their arms or legs, or a cool or pale arm or leg.

The combination of TAFINLAR and MEKINIST can cause heart problems, including heart failure. A patient’s heart function should be checked before and during treatment. Patients should be advised to call their health care provider right away if they have any of the following signs and symptoms of a heart problem: feeling like their heart is pounding or racing, shortness of breath, swelling of their ankles and feet, or feeling lightheaded.

TAFINLAR, in combination with MEKINIST, can cause severe eye problems that can lead to blindness. Patients should be advised to call their health care provider right away if they get: blurred vision, loss of vision, or other vision changes, seeing color dots, halo (seeing blurred outline around objects), eye pain, swelling, or redness.

TAFINLAR, in combination with MEKINIST, can cause lung or breathing problems. Patients should be advised to tell their health care provider if they have new or worsening symptoms of lung or breathing problems, including shortness of breath or cough.

Fever is common during treatment with TAFINLAR in combination with MEKINIST but may also be serious. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Patients should be advised to call their health care provider right away if they get a fever.

Rash and other skin reactions are common side effects of TAFINLAR in combination with MEKINIST. In some cases, these rashes and other skin reactions can be severe or serious, may need to be treated in a hospital, or lead to death. Patients should be advised to call their health care provider if they get any of the following symptoms: blisters or peeling of skin, mouth sores, blisters on the lips or around the mouth or eyes, high fever or flu-like symptoms, and/or enlarged lymph nodes.

Some people may develop high blood sugar or worsening diabetes during treatment with TAFINLAR in combination with MEKINIST. For patients who are diabetic, their health care provider should check their blood sugar levels closely during treatment. Their diabetes medicine may need to be changed. Patients should be advised to tell their health care provider if they have increased thirst, urinate more often than normal, or produce an increased amount of urine.

TAFINLAR may cause healthy red blood cells to break down too early in people with glucose-6-phosphate dehydrogenase deficiency. This may lead to a type of anemia called hemolytic anemia, where the body does not have enough healthy red blood cells. Patients should be advised to tell their health care provider if they have yellow skin (jaundice), weakness or dizziness, or shortness of breath.

TAFINLAR, in combination with MEKINIST, can cause new or worsening high blood pressure (hypertension). A patient’s blood pressure should be checked during treatment. Patients should be advised to tell their health care provider if they develop high blood pressure, their blood pressure worsens, or if they have severe headache, lightheadedness, blurry vision, or dizziness.

For women of reproductive potential, TAFINLAR and MEKINIST, in combination, can harm your unborn baby. Your health care provider will do a test to see if you are pregnant before starting treatment with TAFINLAR and MEKINIST in combination. Use effective birth control (contraception) during treatment with TAFINLAR and MEKINIST in combination, and for 4 months after stopping treatment with TAFINLAR and MEKINIST.

Men (including those who have had a vasectomy) should use condoms during sexual intercourse during treatment with TAFINLAR and MEKINIST and for at least 4 months after the last dose of TAFINLAR and MEKINIST.

The most common side effects for patients with metastatic melanoma receiving the combination are pyrexia, nausea, rash, chills, diarrhea, headache, vomiting, hypertension, arthralgia, peripheral edema, and cough. The most common side effects for patients with stage III melanoma as adjuvant therapy receiving the combination are pyrexia, tiredness, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. The most common side effects for patients with NSCLC receiving the combination are pyrexia, tiredness, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea. The most common side effects for adults with solid tumors that cannot be removed by surgery or have spread to other parts of the body who are receiving the combination are fever, tiredness, nausea, rash, chills, headache, bleeding, cough, vomiting, constipation, diarrhea, muscle and or joint aches, and swelling of arms and legs. The most common side effects for children with solid tumors that cannot be removed by surgery or have spread to other parts of the body who are receiving the combination are fever, rash, vomiting, tiredness, dry skin, cough, diarrhea, acnearea, headache, stomach- (abdomen) pain, nausea, bleeding, constipation, and skin infection around fingernails or toenails. The most common side effects of in children 1 year of age and older with low-grade glioma receiving the combination include fever, rash, headache, vomiting, muscle and bone pain, tiredness, dry skin, diarrhea, nausea, bleeding, stomach area (abdomen) pain, and acne.

Please see full Prescribing Information for TAFINLAR and MEKINIST at View Source and View Source

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