On February 5, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that clinical data from its lead product candidate CB-839, a firstin-class glutaminase inhibitor, will be presented at the 2018 Genitourinary Cancer Symposium, February 8-10, 2018 in San Francisco, California (Press release, Calithera Biosciences, FEB 5, 2018, View Source [SID1234535247]). This is the first disclosure of clinical experience evaluating CB-839 in combination with cabozantinib, an oral receptor tyrosine kinase inhibitor. Preliminary results show the combination demonstrated a 40% overall response rate in advanced clear cell RCC patients, and 100% disease control, with the safety profile of CB-839 plus cabozantinib generally consistent with that of cabozantinib monotherapy. The data will be presented on Saturday February 10, 2018 in Poster Session C: Renal Cell Cancer from 11:30am-1:00pm PT (Board F18).

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"Despite the advances in the treatment of renal cell carcinoma, there remains a significant unmet need in the treatment of patients with advanced disease," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer, and President of Calithera Biosciences. "Based on these promising clinical results, we plan to initiate a global, randomized Phase 2 trial of CB-839 in combination with cabozantinib in the second quarter of 2018, and focus our efforts on developing a potential new therapeutic option that could benefit patients who have failed their first therapies."

Dr. Nizar Tannir from MD Anderson Cancer Center will present the results in a poster session, "Phase I study of glutaminase inhibitor CB-839, combined with everolimus or cabozantinib in patients with clear cell and papillary renal cell carcinoma." As of December 22, 2017, 12 advanced renal cell carcinoma patients were treated with CB-839 plus cabozantinib and evaluable for response, including 10 clear cell patients, and two papillary patients. One hundred percent of evaluable patients experienced tumor shrinkage and disease control; this includes four patients who had a partial response and eight patients who had stable disease. In the clear cell patient population, the disease control rate was 100% and the response rate was 40%. Patients enrolled in the trial had advanced or metastatic disease and had received a median of three prior treatments, which included tyrosine kinase inhibitors, mTOR inhibitors, and checkpoint inhibitors. Patients were administered CB-839 in oral doses that ranged from 600-800 mg twice a day in combination with a fixed oral dose of cabozantinib at 60 mg once a day. On the basis of this efficacy and safety data which compares favorably to treatment with cabozantinib, Calithera plans to initiate the CANTATA trial, a Phase 2 randomized, placebo-controlled trial in approximately 300 clear cell renal cell carcinoma patients whom have previously received one or two prior lines of therapy. Exelixis has entered into a material supply agreement with Calithera. The CANTATA trial is expected to begin in the second quarter of 2018.

The updated results of CB-839 in combination with everolimus were also presented. As of the data cut off, 24 renal cell carcinoma patients, with a median of 3 prior therapies, were treated and evaluable for response. Ninety-two percent (92%) of patients experienced control of their disease, including one patient with a partial response and 21 patients with stable disease. The median progression free survival was 5.8 months, which compares favorably to historical data in this patient population. On the basis of this efficacy and safety data, Calithera plans to continue development in combination with everolimus for the treatment of advanced clear cell renal cell carcinoma. The randomized Phase 2 ENTRATA trial of CB-839 in combination with everolimus in later stage patients is currently enrolling, and has been modified to enroll approximately 65 patients.

About CB-839

Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

On February 5, 2018 Astellas Pharma Inc. (TSE: 4503), President and CEO: Yoshihiko Hatanaka, "Astellas," and Pfizer Inc. (NYSE: PFE) reported results from the Phase 3 PROSPER trial in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC) (Press release, Astellas Pharma US, FEB 5, 2018, View Source [SID1234523731]). The results show that the use of XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone. The median for the primary endpoint, metastasis-free survival (MFS), was 36.6 months for men who received XTANDI compared to 14.7 months with ADT alone (n=1401; HR=0.29 [95% CI: 0.24-0.35]; p<0.0001). These data will be presented at the 2018 Genitourinary Cancers Symposium in San Francisco.

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Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

Marketing applications based on the results of the PROSPER study have been submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA and EMA each have a filing review period during which they evaluate whether an application is complete and acceptable for filing. The data are also being submitted to additional regulatory authorities around the world.

"In patients with non-metastatic CRPC, there is a high unmet need to delay development of metastases and the progression to advanced prostate cancer. There are currently no approved systemic therapies for patients with non-metastatic CRPC in the U.S.," said Maha Hussain, M.D., Robert H. Lurie Comprehensive Cancer Center of Northwestern University, who will present the data. "In the PROSPER trial, treatment with enzalutamide plus ADT delayed the development of metastases compared to standard of care ADT alone and, if approved, may provide men with non-metastatic CRPC an important new treatment option."

PROSPER also investigated time to prostate-specific antigen (PSA) progression, time to first use of new antineoplastic therapy and overall survival (OS) as key secondary endpoints. The analysis demonstrated that patients who received XTANDI plus ADT had a 93 percent reduction in relative risk of PSA progression compared to patients who received ADT alone (HR=0.07 [95% CI: 0.05-0.08]; P<0.0001). XTANDI plus ADT delayed the median time to PSA progression by 33.3 months (37.2 months [95% CI: 33.1-NR] versus 3.9 months with ADT alone [95% CI: 3.8-4.0]).

XTANDI plus ADT prolonged the median time to first use of new antineoplastic therapy by 21.9 months versus ADT alone (39.6 months [95% CI: 37.7-NR] vs. 17.7 months [95% CI: 16.2-19.7]), a 79 percent relative risk reduction (HR=0.21 [95% CI: 0.17-0.26]; p<0.0001). At the time of the first interim analysis, median OS had not yet been reached in either treatment arm. However, these interim results demonstrated a trend in favor of XTANDI that was not statistically significant (HR=0.80 [95% CI: 0.58-1.09]; p=0.1519).

Adverse events in the PROSPER trial were generally consistent with those reported in prior enzalutamide clinical trials in patients with metastatic CRPC. Grade 3 or higher adverse events were reported in 31 percent of men treated with XTANDI plus ADT and in 23 percent of men treated with ADT alone. The most common (≥2%) Grade 3 or higher adverse events that were reported more often in XTANDI plus ADT-treated patients included hypertension (5% vs. 2%) and fatigue (3% vs. 1%). Major adverse cardiovascular events were reported in 5 percent of patients who received XTANDI plus ADT and 3 percent with ADT alone. Three seizures (<1%) were reported with XTANDI plus ADT patients and none were reported for those who received ADT alone. The percentage of patients in whom adverse events were the primary reason leading to treatment discontinuation was low in both study arms (9% with XTANDI plus ADT versus 6% with ADT alone).

About PROSPER
The Phase 3 randomized, double-blind, placebo-controlled, multi-national trial enrolled approximately 1,400 patients with non-metastatic castration-resistant prostate cancer (CRPC) at sites in the United States, Canada, Europe, South America and the Asia-Pacific region. PROSPER enrolled patients with prostate cancer that had progressed, based on a rising prostate-specific antigen (PSA) level despite androgen deprivation therapy (ADT), but who had no symptoms and no prior or present evidence of metastatic disease. The trial evaluated enzalutamide at a dose of 160 mg taken orally once daily plus ADT, versus placebo plus ADT.

The primary endpoint of the PROSPER trial, metastasis-free survival (MFS), is a measure of the amount of time that passes until a cancer can be radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation. Secondary endpoints included time to PSA progression, time to first use of antineoplastic therapy and overall survival.

For more information on the PROSPER trial, go to www.clinicaltrials.gov.

About Castration-Resistant Prostate Cancer
Prostate cancer is the second most common cancer in men worldwide.1 More than 164,000 men in the United States are estimated to be newly diagnosed with prostate cancer in 2018.2 In the European Union, the estimated number of new prostate cancer cases in 2015 was 365,000.3

Castration-resistant prostate cancer (CRPC) refers to the subset of men whose prostate cancer progresses despite castration levels of testosterone.4 Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body (metastases), and there is a rising prostate-specific antigen (PSA) level.5 Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.6

About XTANDI (enzalutamide) capsules
XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

Important Safety Information

Contraindications
XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy.

Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors, seizures were reported in 2.2% of patients. See section 5.1 of the Prescribing Information for the list of predisposing factors. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which 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.

Adverse Reactions
The most common adverse reactions (≥10%) that occurred more commonly (≥2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy-naïve patients, the most common adverse reactions (≥10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss.

In the placebo-controlled study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients.

Lab Abnormalities: In the two placebo-controlled trials, Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).

Infections: In the study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death.

Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.

Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. 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 co-administration 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 February 5, 2018 Varian (NYSE: VAR) reported it has acquired privately-held Mobius Medical Systems, a leader in radiation oncology Quality Assurance (QA) software (Press release, Varian Medical Systems, FEB 5, 2018, View Source [SID1234523897]). This acquisition expands Varian’s leadership in radiation medicine, by increasing its portfolio of patient treatment plan QA and machine QA technologies, and enables the company to potentially impact more patients around the globe with software solutions designed to assure the quality of treatments.

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The acquisition of Mobius is consistent with Varian’s long-term growth and value creation strategy and broadens its cancer care portfolio. The integration of additional QA tools into the Varian ecosystem will allow advanced QA processes to be more seamlessly combined into treatment workflows. Additionally, Varian also can ensure that QA methods advance at the same time as Varian introduces new treatment techniques.

"Varian has a long history of providing high-quality QA for its products and the treatments they deliver," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "Varian places high value on the market-leading Mobius QA products, including Mobius3D and DoseLab, and is dedicated to expanding their global reach. The two companies have similar cultures with deep commitments to enabling quality cancer care for patients around the globe."

The Mobius QA software is in use at over 1000 sites worldwide to ensure patients receive high-quality care. Mobius3D is a 3D dose verification and IMRT/VMAT treatment delivery QA system. Mobius3D performs 3D dose verification for patient plans, supports verification checks throughout the entire clinical process for IMRT and VMAT, and includes modular staged testing to reinforce the confidence of the medical physicist in the patient plan and treatment delivery. DoseLab is fast, simple and powerful software for quality assurance of medical linear accelerators.

For more information about the Mobius products that are now part of the Varian cancer care portfolio, visit www.varian.com/mobius.

On February 5, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported the commercial availability of VIDAZA (azacitidine for injection) in China (Press release, BeiGene, FEB 5, 2018, View Source;p=RssLanding&cat=news&id=2330400 [SID1234523732]). VIDAZA is a nucleoside metabolic inhibitor and was approved in China for patients with Intermediate-2 / High-risk myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) with 20-30% bone marrow blasts and chronic myelomonocyte leukemia (CMML). It is marketed in China by BeiGene under an exclusive license from Celgene Corporation.

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"VIDAZA is the only approved hypomethylating agent shown to prolong survival for patients with MDS, and the first new treatment for MDS patients approved in China since 2009. It is the third approved therapy in our commercial portfolio in China, which we plan to further expand in the coming years. We are excited to announce that the first prescription was made in January 2018. From now on, Chinese patients can benefit from VIDAZA in hospitals around China," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

VIDAZA is recommended by National Comprehensive Cancer Network (NCCN) Guidelines in the U.S. as a front-line treatment. In a global Phase 3 trial (AZA-001) involving Intermediate-2 and High risk MDS patients, VIDAZA significantly prolonged the median overall survival to 24.5 months compared with 15 months for the conventional care regimens (CCR- best supportive care, low-dose cytarabine and intensive chemotherapy) group. In the VIDAZA group, 45% of patients who were dependent on red blood cell transfusions at baseline became transfusion independent compared with 11% in the CCR group. There was a higher objective response rate among patients treated with VIDAZA (49%) as compared to the CCR arm (29%). VIDAZA also delayed the onset of AML for these patients (17.8 months vs.11.5 months). The most common grade 3–4 events were peripheral blood cytopenias for all treatments.

About Myelodysplastic Syndrome, Acute Myeloid Leukemia and Chronic Myelomonocyte Leukemia

MDS is a heterogeneous group of diseases characterized by bone marrow failure and one or more myelodysplasia. In about one-third of patients with MDS, the disease can progress to a rapidly growing cancer of bone marrow cells called AML.i CMML is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood; it affects mainly older adults. CMML has features of both MDS and myeloproliferative disorder and is considered the most common disease among myelodysplastic/myeloproliferative diseases.ii

About VIDAZA (Azacytidine for Injection)

VIDAZA is a nucleoside metabolic inhibitor indicated in China for the treatment of patients with intermediate-2 / high-risk MDS, AML with 20-30% bone marrow blasts and CMML. It is marketed in China by BeiGene under an exclusive license from Celgene Corporation.

In the U.S. VIDAZA is indicated for the treatment of patients with the following FAB MDS subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and CMML.

Important Safety Information

VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors.

In Study 1 (a randomized, open-label, controlled trial carried out in 53 U.S. sites compared the safety and efficacy of subcutaneous VIDAZA plus supportive care with supportive care alone ("observation") in patients with any of the five FAB subtypes of myelodysplastic syndromes (MDS)) and Study 2 (a multi-center, open-label, single-arm study of 72 patients with RAEB, RAEB-T, CMMoL, or AML), the most commonly occurring adverse reactions by SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%), and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%). In Study 3, the most common adverse reactions by IV route also included petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia (31.3%).

In Study 4 (the AZA-001 survival trial), the most commonly occurring adverse reactions were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%), and febrile neutropenia (12.6%).

Because treatment with VIDAZA is associated with anemia, neutropenia and thrombocytopenia, complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle.

Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease. In addition, azacitidine and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.

VIDAZA may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be apprised of the potential hazard to the fetus. Men should be advised not to father a child while receiving VIDAZA.

Nursing mothers discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

On February 5, 2018 Yuhan Corporation (KRX:000100.KS) (Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq:SRNE) (Sorrento) reported that the South Korean Ministry of Food and Drug Safety (MFDS) has approved ImmuneOncia Therapeutics’ (51% Yuhan/49% Sorrento joint venture formed in March 2016) IND for the initiation of clinical trials for Sorrento-discovered anti-PD-L1 monoclonal antibody STI-A1015 (IMC-001), which is exclusively licensed to ImmuneOncia for select regional markets by Sorrento (Press release, ImmuneOncia Therapeutics, FEB 5, 2018, View Source [SID1234531898]).

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Yuhan had initially contributed more than $10M to the formation of ImmuneOncia and towards the development of IMC-001, with a commitment of additional funding for clinical development of IMC-001. Sorrento contributed its antibody STI-A1015 (IMC-001) and two other antibodies, as well as cGMP manufacturing and regulatory expertise support for the data submission package for the IND.

The clinical Phase 1 studies will enroll patients suffering from solid tumors at two clinical sites in South Korea, namely, Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC).

"We are proud to announce the acceptance of the IND by MFDS for our anti-PD-L1 antibody IMC-001. Throughout the IND-enabling activities, our team has worked collaboratively with our Sorrento colleagues to generate a high-quality submission package that was very well received by MFDS", said Dr. Kwang Ho Cheong, CEO of ImmuneOncia Therapeutics.

"Yuhan is proud of this outstanding achievement by Dr. Cheong and the ImmuneOncia team. Together with our friends and partners from Sorrento, we created ImmuneOncia to develop important immunotherapies for cancer patients in South Korea and worldwide. Through our investment in ImmuneOncia, Yuhan has become a true biopharmaceutical company. We look forward to the future success of IMC-001 and the other antibody programs in ImmuneOncia’s pipeline", said Mr. Jung Hee Lee, CEO and President of Yuhan Corporation.

"We are very pleased with the progress made by our joint venture in the past year. We believe this is additional validation of our antibody technology as well as our in-house cGMP antibody manufacturing and development capabilities. Notably, Sorrento has retained the rights for STI-A1015 (IMC-001) in many major markets, including the EU, Japan and the US, and we intend to leverage ImmuneOncia’s clinical work to support our clinical development in these territories where we retain rights to STI-A1015 (IMC-001). We also think the success of ImmuneOncia further highlights our ability to create shareholder value through productive strategic partnerships," added Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics.

ImmuneOncia is exploring being publicly-listed on the South Korea Stock Exchange (KSEX) in 2019, which could result in additional sources of non-dilutive capital for Sorrento.

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody