Full Press Release Details
THOUSAND OAKS, Calif. , May 19, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced that new data from its expanding oncology pipeline and marketed portfolio will be presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place virtually from June 4-8, 2021 .
Overall survival (OS) data from the Phase 2 CodeBreaK 100 trial of LUMAKRAS™ (sotorasib), a potentially first-in-class KRAS G12C inhibitor in non-small cell lung cancer (NSCLC) will be presented for the first time alongside additional exploratory biomarker subgroup analyses in an oral presentation on Friday, June 4, 2021 . Updated data for investigational bemarituzumab in combination with chemotherapy from the Phase 2 FIGHT trial will also be shared in an oral presentation on Friday, June 4, 2021 , in patients with FGFR2b+ advanced gastric and gastroesophageal junction adenocarcinoma (GEJ).
Additional research to be presented at ASCO includes updated safety and efficacy data from the first-in-human (FIH) study of AMG 757 (tarlatamab) in small cell lung cancer (SCLC). Tarlatamab is an investigational first-in-class half-life extended (HLE) bispecific T-cell engager (BiTE ® ) molecule that is uniquely designed to target delta-like ligand 3 (DLL3) in neuroendocrine cancers such as small cell lung cancer (SCLC) and neuroendocrine prostate cancer.
Investigator sponsored study (ISS) presentations include new oral data presentations from the PANAMA trial evaluating VECTIBIX ® (panitumumab) in combination with 5-fluorouracil/leucovorin (5FU/LV) as maintenance therapy in metastatic colorectal cancer (mCRC), and new data from the CHRONOS trial evaluating anti-EGFR rechallenge therapy with Vectibix in mCRC.
Abstracts are available on the ASCO website .
Amgen Webcast Investor Call Amgen will host a webcast call for the investment community in conjunction with ASCO on Friday, June 4, 2021 at 4:00 p.m. ET. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team will discuss clinical data being presented on the Company's investigational KRAS G12C inhibitor LUMAKRAS ™ , anti-FGFR2b antibody bemarituzumab and DLL3-targeting HLE BiTE ® tarlatamab.
Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
Key Abstracts and Presentation Times:
AMG 757 (Tarlatamab)
AMG 160 (Acapatamab)
BLINCYTO ® (blinatumomab)
IMLYGIC ® (talimogene laherparepvec)
VECTIBIX ® (panitumumab)
Investigator Sponsored Studies (ISS)
XGEVA ® (denosumab)
Learn more about Amgen's development of innovative medicines for novel targets in difficult-to-treat solid tumors at AmgenOncology.com
About LUMAKRAS™ (sotorasib) Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, an investigational KRAS G12C inhibitor. 2 LUMAKRAS was the first KRAS G12C inhibitor to enter the clinic and is being studied in the largest clinical program exploring 11 combinations with global sites spanning five continents. In just under three years from first patient dosed, the LUMAKRAS clinical program CodeBreaK has established the deepest clinical data set with more than 800 patients studied across 13 tumor types.
LUMAKRAS has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. LUMAKRAS is also being studied in multiple other solid tumors. 2,3
About CodeBreaK The CodeBreaK clinical development program for Amgen's drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumor types since its inception.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.
A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in KRAS G12C-mutated NSCLC patients (CodeBreaK 200) completed enrollment in April 2021 . Amgen has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.
About Bemarituzumab Bemarituzumab (anti-FGFR2b) is a potential first-in-class investigational targeted antibody that is designed to block specific fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. The company is also evaluating the potential for bemarituzumab in other cancers that overexpress FGFR2b. In April 2021 , bemarituzumab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration.
Zai Lab ( Shanghai ) Co. Ltd. was granted an exclusive license to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.
About BiTE ® Technology BiTE ® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage a patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing BiTE molecules across a broad range of hematologic malignancies and solid tumors and further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.
About BLINCYTO ® (Blinatumomab) BLINCYTO is a BiTE ® (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.
BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration and is approved in the U.S. for the treatment of:
In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
Contraindications
BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
Adverse Reactions
Dosage and Administration Guidelines
Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com .
About IMLYGIC ® (talimogene laherparepvec) IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. The exact mechanism of action continues to be investigated.
IMLYGIC is the first and only oncolytic viral therapy approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory authorities, based on therapeutic benefit demonstrated in a pivotal Phase 3 study. IMLYGIC is indicated for the local treatment of melanoma in patients with unresectable cutaneous, subcutaneous, or nodal lesions after initial surgery.
The IMLYGIC clinical program continues to investigate the role of IMLYGIC both as monotherapy and in combination with other therapies across a variety of cancers and treatment settings.
INDICATION & LIMITATIONS OF USE IMLYGIC ® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Limitations of use: IMLYGIC ® has not been shown to improve overall survival or have an effect on visceral metastases.
IMPORTANT SAFETY INFORMATION
Contraindications
Warnings and Precautions
Adverse Reactions
Please see www.Imlygic.com for full Prescribing Information, including Medication Guide.
About Vectibix ® (panitumumab) Vectibix is the first fully human monoclonal anti-EGFR antibody approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.
In June 2017, the FDA approved a refined indication for Vectibix for use in in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use ) mCRC.
INDICATION AND LIMITATION OF USE Vectibix ® is indicated for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC): as first-line therapy in combination with FOLFOX, and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.
Limitation of Use: Vectibix ® is not indicated for the treatment of patients with RAS mutant mCRC or for whom RAS mutation status is unknown.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].
To see the Vectibix ® Prescribing Information, including Boxed Warning visit www.vectibix.com .
About XGEVA ® (denosumab) XGEVA targets the RANKL pathway to prevent the formation, function and survival of osteoclasts, which break down bone. XGEVA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. XGEVA is also indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
INDICATIONS XGEVA ® is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. XGEVA ® is indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. XGEVA ® is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
IMPORTANT SAFETY INFORMATION
Hypocalcemia Pre-existing hypocalcemia must be corrected prior to initiating therapy with XGEVA ® . XGEVA ® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Monitor calcium levels, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when XGEVA ® is administered with other drugs that can also lower calcium levels. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.
An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.
Hypersensitivity XGEVA ® is contraindicated in patients with known clinically significant hypersensitivity to XGEVA ® , including anaphylaxis that has been reported with use of XGEVA ® . Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue XGEVA ® therapy permanently.
Drug Products with Same Active Ingredient Patients receiving XGEVA ® should not take Prolia ® (denosumab).
Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ) has been reported in patients receiving XGEVA ® , manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure.
Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a greater risk to develop ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.
Perform an oral examination and appropriate preventive dentistry prior to the initiation of XGEVA ® and periodically during XGEVA ® therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with XGEVA ® . Consider temporarily interrupting XGEVA ® therapy if an invasive dental procedure must be performed.
Patients who are suspected of having or who develop ONJ while on XGEVA ® should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.
Atypical Subtrochanteric and Diaphyseal Femoral Fracture Atypical femoral fracture has been reported with XGEVA ® . These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.
Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During XGEVA ® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of XGEVA ® therapy should be considered, pending a risk/benefit assessment, on an individual basis.
Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in XGEVA ® -treated patients with GCTB and in patients with growing skeletons within one year of treatment discontinuation. Monitor patients for signs and symptoms of hypercalcemia after treatment discontinuation and treat appropriately.
Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation Multiple vertebral fractures (MVF) have been reported following discontinuation of treatment with denosumab. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When XGEVA ® treatment is discontinued, evaluate the individual patient's risk for vertebral fractures.
Embryo-Fetal Toxicity XGEVA ® can cause fetal harm when administered to a pregnant woman. Based on findings in animals, XGEVA ® is expected to result in adverse reproductive effects.
Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of XGEVA ® . Apprise the patient of the potential hazard to a fetus if XGEVA ® is used during pregnancy or if the patient becomes pregnant while patients are exposed to XGEVA ® .
Adverse Reactions The most common adverse reactions in patients receiving XGEVA ® with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia.
For multiple myeloma patients receiving XGEVA ® , the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction was pneumonia. The most common adverse reaction resulting in discontinuation of XGEVA ® was osteonecrosis of the jaw.
The most common adverse reactions in patients receiving XGEVA ® for giant cell tumor of bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. The most common serious adverse reactions were osteonecrosis of the jaw and osteomyelitis.
The most common adverse reactions resulting in discontinuation of XGEVA ® were osteonecrosis of the jaw and tooth abscess or tooth infection.
The most common adverse reactions in patients receiving XGEVA ® for hypercalcemia of malignancy were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.
Please visit www.xgeva.com for Full U.S. Prescribing Information.
About Amgen Oncology At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.