Pharmacyclics invites OSCO members to Product Theatre Program at SOHO.

Pharmacyclics invites OSCO members to their Product Theatre program discussing IMBRUVICA® (ibrutinib) during the Society of Hematologic Oncology’s Annual Conference in Houston Texas.   See Details in the Invite Below and click on this link to register:  Product Theatre Registration

Additional information about SOHO is available at their website  SOHO 2022 Annual Meeting.

The US Food and Drug Administration (FDA) has approved a new indication for IMFINZI® (durvalumab), in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).1

BTCs comprise a heterogeneous group of rare cancers, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, that account for approximately 1% of all new cancer cases annually in the United States.2-5 The majority of BTCs (about 60% to 70%) are diagnosed as unresectable or metastatic disease,6 and more than 10 years have passed since gemcitabine plus cisplatin (gem-cis) was established as the standard of care in the first-line systemic treatment of advanced BTCs.7,8

IMFINZI, in combination with gem-cis, was studied in 685 patients with locally advanced or metastatic BTCs in the Phase III, randomized, double-blind, placebo-controlled, multicenter, global TOPAZ-1 trial, results of which were published in the June 2022 issue of NEJM Evidence.9 In this trial, IMFINZI + gem-cis demonstrated significant improvement in the primary endpoint of overall survival (OS) vs gem-cis + placebo1,9:

  • 20% lower risk of death vs gem-cis + placebo (HR=0.80 [95% CI: 0.66-0.97]; P=0.021)*
  • Median OS: 12.8 months (95% CI: 11.1-14) with IMFINZI + gem-cis vs 11.5 months (95% CI: 10.1-12.5) with gem-cis + placebo
  • 24-month OS: 24.9% (95% CI: 17.9-32.5) with IMFINZI + gem-cis and 10.4%              (95% CI: 4.7-18.8) with gem-cis + placebo
    • OS at 12, 18, and 24 months were descriptive endpoints and were not formally tested for statistical significance

Serious adverse reactions occurred in 47% of patients receiving IMFINZI + gem-cis. The most frequent (≥2% of patients) were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI + gem-cis and included ischemic or hemorrhagic stroke (reported in 4 patients), sepsis, and upper gastrointestinal hemorrhage (reported in 2 patients each).1

Based on these results, the FDA granted IMFINZI, in combination with gem-cis, priority review status in May 2022 and full approval on September 2, 2022 —making it the first [and only] FDA-approved regimen for the first-line treatment of patients with locally advanced or metastatic BTCs.1,10,11

Additionally, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers recommend durvalumab (IMFINZI®) in combination with gemcitabine + cisplatin as a Category 1, preferred systemic therapy option for primary treatment of patients with unresectable or metastatic BTCs.12†

INDICATIONS

  • IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
  • IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
  • IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Please see complete Prescribing Information including Medication Guide.

You may report side effects related to AstraZeneca products by clicking here.

Thanks to @SenatorLankford, the Medicare #MCED Screening Coverage Act now has 51 cosponsors in the Senate! This bill is a must-pass for Oklahoma seniors, who deserve to access the best possible tools to detect cancer early.

On August 24, 2022, the Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.

For more information, read the FDA Announcement or Press Release.

On August 16, President Biden signed the Inflation Reduction Act—a broad climate, tax, and healthcare reconciliation bill—into law. The law extends ACA tax credit subsidies, allows Medicare to negotiate prescription drug prices, places inflationary caps on price increases for Medicare Part B and Part D drugs, and limits Medicare beneficiaries’ out-of-pocket spending on Part D prescription drugs. ASCO supports the intent of the law, which is to reduce the cost of prescription drugs and lower patient out of pocket spending. However, ASCO and other specialty societies are concerned that the drug price negotiation provision will negatively impact patient access to critical Part B prescription drugs and asked Congress to offset cuts to Part B reimbursement. Key provisions in the law that will impact cancer care include:  Drug Price Negotiation – The law directs HHS to negotiate the price of a set number of drugs within Medicare Part B and Part D. The Secretary of HHS will negotiate maximum fair prices for 10 Part D drugs in 2026, 15 Part D drugs in 2027, 15 Part B or D drugs in 2028, and 20 Part B or D drugs in 2029 and beyond. These changes are not expected to affect oncology practices until 2028. Prescription drug inflation rebates – The law requires manufacturers to provide rebates to the government if the price of certain drugs increase above inflation. The Part D rebates begin in October 2022, and the Part B rebates begin in January 2023. Medicare Part B coinsurance protection – An inflation growth cap for Part B beneficiary coinsurance begins in April 2023. Medicare Part D – An out-of-pocket spending cap begins in 2024. Other updates include: • Starting in 2024, beneficiaries will owe $0 out-of-pocket for Part D drugs in the catastrophic phase. By 2025, beneficiary out-of-pocket spending will be capped at $2,000 per year. • The income threshold for the Part D low-income subsidy has been expanded from 135% to 150% of the federal poverty level. • A redesign of program benefits will take place in 2025. • Premium growth will be capped at 6% per year through 2029. • HHS is authorized make a one-time adjustment to the beneficiary Part D premium percentage in 2030 to provide longer-term premium protection. • $0 cost-sharing for vaccines goes into effect in January 2023. • Repeal of the rebate rule begins in January 2027. ACA – Premium tax credit subsidies are extended through 2025.

Read the Full Prescribing Information

AstraZeneca recently announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti–HER2-based regimen either: in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.1 ENHERTU has Boxed WARNINGS for Interstitial Lung Disease (ILD)/Pneumonitis and Embryo-Fetal Toxicity. Please see Important Safety Information below.

Please see below and attached resources for additional information on ENHERTU in 2L HER2+ mBC.

NCCN RECOMMENDATION

·         NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends fam-trastuzumab deruxtecan-nxki (ENHERTU) as the Category 1 preferred regimen over T-DM1 as second-line therapy for recurrent unresectable (local or regional) or stage IV HER2+ disease2, a

aFam-trastuzumab deruxtecan-nxki may be considered in the first-line setting as an option for select patients (ie, those with rapid progression within 6 months of neoadjuvant or adjuvant therapy [12 months for pertuzumab-containing regimens]). Regimen may also be used as an option for third-line and beyond; the optimal sequence for third-line therapy and beyond is not known2

RECOMMENDED DOSAGE

In unresectable or metastatic HER2-positive breast cancer, the recommended dosage of ENHERTU is 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.1 This recommended dosage is specific to the indication.

ENHERTU PACKAGE INFORMATION

Vial size1NDC1Wholesale acquisition cost (WAC)J-code3
One 100 mg single-dose vial65597-406-01$2330.41J9358

ATTACHMENTS

·         Endpoints Brochure: summarizes pivotal DESTINY-Breast03 trial that evaluated ENHERTU vs T-DM1

As a reminder, the ENHERTU4U website contains a suite of Access and Reimbursement resources and program information. Please visit https://www.enhertu4u.com/ for more information.

Important Safety Information

Indication

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:

•         In the metastatic setting, or

•         In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six     months of completing therapy

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease / Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. In clinical studies, of the 491 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 13% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 1.4% of patients treated with ENHERTU. Median time to first onset was 5.5 months (range: 1.1 to 20.8).

Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. In clinical studies, of the 491 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 68% of patients. Eighteen percent had Grade 3 or 4 decrease in neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 6 to 664). Febrile neutropenia was reported in 1.2% of patients.

Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 491 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4 mg/kg, 13 cases (2.6%) of asymptomatic LVEF decrease were reported.

Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

Embryo-Fetal Toxicity 

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

Additional Dose Modifications

Thrombocytopenia

For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by one level.

Adverse Reactions

The pooled safety population for patients with metastatic breast cancer reflects exposure to ENHERTU at 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) in 491 patients in DESTINY-Breast03, DESTINY-Breast01, and Study DS8201-A-J101. The median duration of treatment was 13 months (range: 0.7 to 37). In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (78%), decreased white blood cell count (74%), decreased hemoglobin (68%), decreased neutrophil count (68%), increased aspartate aminotransferase (58%), fatigue (57%), decreased lymphocyte count (56%), vomiting (50%), decreased platelet count (49%), increased alanine aminotransferase (48%), increased blood alkaline phosphatase (45%), alopecia (41%), constipation (35%), hypokalemia (33%), decreased appetite (32%), diarrhea (31%), musculoskeletal pain (28%), increased transaminases (27%), respiratory infection (24%), headache (21%), and abdominal pain (21%).

DESTINY-Breast03

The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast03. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 14 months (range: 0.7 to 30).

Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, interstitial lung disease, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (one patient each).

ENHERTU was permanently discontinued in 14% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, neutropenia, and fatigue.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), hypokalemia (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), respiratory infection (22%), headache (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%).

Use in Specific Populations

  • Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.
  • Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
  • Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.
  • Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.
  • Geriatric Use: Of the 491 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 22% were ≥65 years and 4% were ≥75 years. No overall differences in efficacy within clinical studies were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (60%) as compared to younger patients (49%).
  • Renal Impairment: A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Monitor patients with moderate or severe renal impairment.
  • Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor.

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA

at 1-800-FDA-1088 or fda.gov/medwatch

The US Food and Drug Administration (FDA) has approved a new indication for LYNPARZA® (olaparib) for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

LYNPARZA is the first and only targeted adjuvant therapy with an FDA-approved indication specifically for patients with gBRCAm,HER2-negative, high-risk early breast cancer for patients who have been treated with neoadjuvant or adjuvant chemotherapy.

FDA approval was based on the results from the OlympiA phase 3 trial, which was presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.

This is the eighth indication approved for LYNPARZA in the US. 

See Important Safety Information below.

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

   WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS/AML was 2 years (range: <6 months to >10 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

INDICATION

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please see complete Prescribing Information, including Medication Guide.

You may report side effects related to AstraZeneca products by clicking here. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

The Oklahoma Society of Clinical Oncology, Inc. would like to invite you to attend our 2022 Spring meeting. Join your colleagues to hear highlights from this state-of-the art symposium on the experimental biology, etiology, prevention, diagnosis and therapy of breast cancer and premalignant breast disease. The “Best of” SABCS is an officially licensed program of the San Antonio Breast Cancer Symposium.  This virtual symposium is directed towards Hematologists and Oncologists, Nurses, Pharmacists, Physician Assistants and other health care professionals specializing in Oncology.  This meeting will break down the most clinically relevant abstracts from the SABCS annual symposium, providing attendees to hear the latest strategies in oncology education.  Note:  There is no fee for physicians and allied health personnel to attend, but meeting registration is required. 

“Best of” SABCS®” is an officially licensed program provided through Encore Medical Education.

This conference is jointly provided by Postgraduate Institute for Medicine and Oklahoma Society of Clinical Oncology, Inc.

This activity has been approved for a maximum of 3.5 AMA PRA Category 1 Credit(s)™and 3.5 contact hours for Continuing Nursing Education.

View Agenda & Register Here

Clinical utility study in stage I-IV colorectal cancer (CRC) evaluates how adjuvant treatment decisions are impacted by using the Signatera™ MRD test

Natera, Inc. (NASDAQ: NTRA) a global leader in cell-free DNA testing, today announced a milestone with over 100 sites initiated and 1,000 patients enrolled across the U.S. in its BESPOKE CRC study, a prospective, multi-center trial to measure the clinical impact of serial testing with Signatera in resectable CRC.

Since its initial launch in January 2020, interest in the outcome of this trial has grown among oncologists nationwide, with a current target to enroll over 2,000 CRC patients across different stages of disease and to follow them for up to 5 years post surgery. The primary objectives of the study are to quantify the real-world impact of Signatera testing on both adjuvant treatment decisions and clinical outcomes, compared to a historical control group. The investigators plan to conduct an interim analysis later in 2022, for presentation at a future scientific congress.

“After the positive interim results from the CIRCULATE-Japan trial, we are eagerly awaiting results from BESPOKE CRC,” said Scott Kopetz, M.D., Ph.D., FACP, chair of the Colon Cancer Task Force at the National Cancer Institute, deputy department chair at the M.D. Anderson Cancer Center and coordinating investigator in the BESPOKE CRC trial. “This study will give us important real-world insight into the implementation and utility of personalized MRD assessment in clinical practice.”

“We are pleased to reach this milestone as patient recruitment continues to accelerate,” said Adham Jurdi, M.D., medical director of oncology at Natera. “This momentum speaks to the growing interest of Signatera among the oncology community, as a highly accurate tool to inform decision-making in the adjuvant and surveillance settings.”

BESPOKE CRC is one among dozens of clinical trials evaluating the clinical utility of Signatera to inform treatment decisions across a range of solid tumors. In CRC specifically, this complements the CIRCULATE-Japan and CIRCULATE-US trials, both prospective, randomized, multi-center trials investigating whether MRD-negative CRC patients benefit from adjuvant chemotherapy. Interim results were recently presented from the CIRCULATE-Japan trial, showing that Signatera is predictive of treatment benefit in early-stage CRC.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., pr@natera.com