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Incyte to Present at Upcoming Investor Conferences

On August 22, 2019 Incyte Corporation (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of September (Press release, Incyte, AUG 22, 2019, View Source [SID1234538934]):

Schedule your 30 min Free 1stOncology Demo!
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Morgan Stanley 17th Annual Global Healthcare Conference on Tuesday, September 10, 2019 at 12:55 pm (EDT) in New York; and
Bank of America Merrill Lynch Global Healthcare Conference on Wednesday, September 18 at 12:10 pm (BST) in London, England
The presentations will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcast should log on before the start time in order to download any software required.

Tecentriq, an Anti-PD-L1 Antibody, Receives Approval for Additional Indication of Extensive-Stage Small Cell Lung Cancer

On August 22, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, "Tecentriq Intravenous Infusion 1200mg" [generic name: atezolizumab (genetical recombination)] from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of "extensive-stage small cell lung cancer (Press release, Chugai, AUG 22, 2019, View Source [SID1234538932])."

"Tecentriq is the first cancer immunotherapy for the treatment of aggressive and difficult-to-treat extensive-stage small cell lung cancer," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "We are very pleased that we can deliver Tecentriq as a potential new standard of care for the treatment of extensive-stage small cell lung cancer which has had limited therapeutic options for a long period of time."

This approval is based on the results from the phase I/III IMpower133 study. Tecentriq in combination with chemotherapy met the primary endpoint of overall survival (OS) as compared with chemotherapy alone in the intent to treat (ITT) analysis (median OS, 12.3 vs 10.3 months; hazard ratio=0.70, 95% confidence interval, 0.54-0.91; p=0.0069). The study also met co-primary endpoint of progression-free survival (PFS) (median PFS, 5.2 vs 4.3 months; hazard ratio=0.77, 95% confidence interval, 0.62-0.96; p=0.017). The safety profile of Tecentriq in combination with chemotherapy was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified.

Roche’s Tecentriq in combination with chemotherapy helped people live significantly longer as an initial treatment for people with extensive-stage small cell lung cancer (Press release issued by Roche on September 25, 2018)
View Source

As a top pharmaceutical company in the field of oncology in Japan, Chugai is committed to contribute to patients and medical professionals by offering Tecentriq as a new treatment option.

Prescribing Information *The underlined parts were newly added.
[Indications]

Unresectable, advanced or recurrent non-small cell lung cancer
Extensive-stage small cell lung cancer
[Dosage and administration]

In case of patients with untreated unresectable, advanced or recurrent non squamous non-small cell lung cancer.
The usual adult dosage is 1200 mg atezolizumab (genetical recombination) in combination with carboplatin, paclitaxel and bevacizumab (genetical recombination) by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
In case of patients with unresectable, advanced or recurrent non squamous non-small cell lung cancer who has undergone chemotherapy.
The usual adult dosage is 1200 mg atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
In case of patients with extensive-stage small cell lung cancer.
The usual adult dosage is 1200 mg atezolizumab (genetical recombination) in combination with carboplatin and etoposide by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
About small cell lung cancer
In Japan, 125,100 people (84,500 men and 40,600 women; 2018 predicted values) are estimated to be afflicted with lung cancer each year. 77,500 people in Japan (55,100 men and 22,400 women; 2018 predicted values) die as a result of the disease. Lung cancer is the leading cause of cancer death. Lung cancer can be broadly divided into small cell lung cancer (SCLC) and non-small cell lung cancer according to the tissue type, with SCLC accounting for approximately 10 to 15% of all lung cancer cases. SCLC has a high tumor-proliferative capacity, and characteristically causes a wide range of metastases rapidly after tumor diagnosis.

About application status of Tecentriq in Japan
Tecentriq was launched in April 2018 with an indication of "unresectable, advanced or recurrent non-small cell lung cancer," followed by an approval for the additional dosing for the treatment of "untreated unresectable, advanced or recurrent non squamous non-small cell lung cancer" in December 2018. In addition, a supplementary application for breast cancer has been submitted to the MHLW in December 2018.

Trademarks used or mentioned in this release are protected by law.

Sources

Cancer Registry and Statistics. Cancer Information Service, National Cancer Center Japan on;
View Source Accessed July 2019.
Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, et al. Changing epidemiology of small cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24:4539-44.
The 5th Revised Edition of New Clinical Oncology, compiled by Japanese Society of Medical Oncology (Nankodo)
Eilas DA. Small cell lung cancer: state-of-the-art therapy in 1996. Chest. 1997 Oct; 112: 251S-258S

Taiho Pharmaceutical Obtains Additional Indication of Gastric Cancer in Japan for Its Anticancer Agent LONSURF®

On August 22, 2019 Taiho Pharmaceutical Co., Ltd. reported that the Japanese Ministry of Health, Labour and Welfare has approved an additional indication of unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy for its anticancer agent LONSURF combination tablet T15, T20 (trifluridine/tipiracil, TAS-102) (Press release, Taiho, AUG 22, 2019, View Source [SID1234538931]).

This approval is based on data from global, randomized Phase III study (TAGS) evaluating trifluridine/tipiracil versus placebo in patients with metastatic gastric cancer refractory to standard treatments. In the TAGS trial, the primary endpoint of overall survival (OS) was extended significantly with trifluridine/tipiracil compared to a placebo, and no new safety signals were observed with the study drug.

Taiho Pharmaceutical believes that LONSURF will make a positive contribution as a treatment option for patients with gastric cancer.

About TAGS
TAGS (TAS-102 Gastric Study) is a Taiho-sponsored, global, randomized, double-blind Phase III study evaluating trifluridine/tipiracil (TAS-102) plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. The primary endpoint in the TAGS trial was OS, and the main secondary endpoint measures included progression-free survival (PFS), safety and tolerability, as well as quality of life. The TAGS trial aimed to enroll 500 adults 18 years and older with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The trial enrolled 507 subjects and was conducted in 17 countries and 110 sites around the world.

For more information on the TAGS trial, please visit: View Source

About LONSURF
LONSURF is an oral anticancer drug which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical has been marketing LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. Since receiving FDA approval in 2015, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, has been marketing LONSURF in the United States for metastatic colorectal cancer (mCRC) refractory to prior therapy.

Taiho Pharmaceutical and Servier* have an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico, and Asia. In parts of Asia outside of Japan, Taiho Pharmaceutical’s business partner TTY Biopharm launched LONSURF in Taiwan in 2018, and JEIL Pharmaceutical is preparing to bring the drug to market in South Korea.

As of July 2019, LONSURF has been approved as a treatment for advanced mCRC in 68 countries and regions worldwide. Additionally, LONSURF was approved as a treatment for metastatic gastric cancer in the United States in February 2019. In the European Union, on July 2019 the CHMP has issued a positive opinion for LONSURF as monotherapy for the treatment of adult patients with metastatic gastric cancer. The CHMP’s opinion has been sent to the European Commission (EC) for the adoption of the decision.

Genmab Announces Approval of DARZALEX® (daratumumab) in Frontline Multiple Myeloma in Japan

On August 22, 2019 Genmab A/S (Nasdaq: GMAB) reported that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Genmab, AUG 22, 2019, View Source [SID1234538928]). DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize the product. Genmab will receive a USD 7 million milestone payment from Janssen in connection with the approval and first commercial sale of DARZALEX under the newly expanded label. The approval and related milestone do not impact the financial guidance issued by Genmab on August 14, 2019.

"Multiple myeloma remains one of the most common forms of blood cancer in Japan and as such, we are encouraged that patients in Japan newly diagnosed with this disease now have the option to receive a DARZALEX containing regimen," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval is based on data from the Phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50 percent in newly diagnosed ASCT ineligible multiple myeloma patients when daratumumab is combined with bortezomib, melphalan and prednisone. This data was presented as a Late-Breaking Abstract at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and published in The New England Journal of Medicine in December 2017.

About the ALCYONE study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter study that included 706 newly diagnosed patients with multiple myeloma who are ineligible for ASCT. Patients were randomized to receive 9 cycles of either VMP [bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid)] combined with daratumumab, or VMP alone. In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for six weeks (cycle 1; 1 cycle = 42 days), once every three weeks from cycles 2 to 9, once every four weeks from cycle 9 until disease progression. The primary endpoint of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 6,313 new patients were expected to be diagnosed with multiple myeloma and approximately 4,338 people were expected to die from the disease in Japan in 2018.2 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma and in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

Nordic Nanovector ASA – Results for the Second Quarter and First Half 2019

On August 22, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the second quarter and first half 2019 (Press release, Nordic Nanovector, AUG 22, 2019, View Source;results-for-the-second-quarter-and-first-half-2019-300905662.html [SID1234538916]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

Eduardo Bravo, CEO, commented: "We continue to progress our clinical development programmes with Betalutin in major NHL indications. In PARADIGME, we have reached our target range in terms of activated sites and while the recruitment rate has accelerated in recent months, this has not been at the rate we anticipated. This has led us to reassess the trial timelines and we now estimate to complete patient enrolment in 2H 2020 rather than 1H 2020 as previously guided. We would expect the data read-out from the trial a few months after the final patient has been dosed. As a one-off treatment, Betalutin has an exciting product profile, and we have been encouraged by the preliminary analysis of the extended median duration of response data that we have disclosed today. We remain focused on advancing PARADIGME and our other clinical programmes as quickly as possible given the clear benefits that Betalutin could deliver to NHL patients around the globe."

Highlights

Preliminary analysis shows median duration of response (mDoR) of 13.5 months (formerly 9.0 months in December 2018) for Phase 1/2a LYMRIT 37-01 trial of Betalutin in R/R FL
Pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) progressing with 81 sites in 23 countries open for enrolment as of August 21st, 2019
Patient recruitment has accelerated in recent months but not at the rate anticipated
Full enrolment now expected 2H 2020 compared with 1H 2020 as previously guided
Phase 1b Archer-1 trial of Betalutin plus rituximab (RTX) in patients with relapsed/refractory (R/R) 2nd line FL advanced into second cohort
Global patent portfolio strengthened with grant of European patent covering the use of Betalutin (and other anti-CD37 targeting agents) in combination with anti-CD20 antibodies (including rituximab) for the treatment of non-Hodgkin’s lymphoma (NHL)
Promising preclinical results from R&D collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours presented at international scientific congresses (TAT11 and TRP19)
Recruitment completed for dose escalation phase of LYMRIT 37-05 trial of Betalutin in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) – preliminary results expected in 2H 2019
Dr Lars Nieba appointed as Chief Technology Officer to drive the company’s CMC strategy
Financial Highlights Q2 and 1H’19

(Figures in brackets = same period 2018 unless otherwise stated)

Revenues for the second quarter amounted to NOK 0.0 (NOK 0.0 million). Revenues for the first half of 2019 were NOK 0.0 (NOK 0.0 million).
Total operating expenses for the second quarter were NOK 111.0 million (NOK 84.5 million). Total operating expenses for the first half of 2019 amounted to NOK 200.9 million (NOK 166.8 million)
Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 77 % of total operating expenses (72.2 %) for the first half of 2019.
Comprehensive loss for the second quarter amounted to NOK 110.4 million (loss of NOK 82.9 million). Comprehensive loss for the first half was NOK 202.0 million (loss of NOK 173.6 million)
Cash and cash equivalents amounted to NOK 443.5 million at the end of June 2019 (NOK 570.1 million at June 2018 and NOK 440.1 million at 31 December 2018)
Upcoming R&D Day

Nordic Nanovector is planning to host and R&D Day in September. During the event the senior management team and external speakers will provide updates and further information on the company’s key activities. The R&D Day will take place in Oslo and will also be webcast live. Details on the date and how to register to attend will be announced within the next two weeks.

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical trial. The company’s pivotal Phase 2b PARADIGME trial with a once-only administration of Betalutin in 3L R/R FL is underway. Patient enrolment is expected to be completed in the second half of 2020. A data read-out is expected a few months after the final patient is dosed enabling filing for marketing approval in the first half of 2021.

The company maintains its guidance that current cash resources are expected to be sufficient to reach mid-2020.

Nordic Nanovector intends to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies and antibody drug conjugates across NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30am CEST at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: AKER

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2019 from 7:00am CEST the same day.