On December 21, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application for humanized anti-PD-L1 monoclonal antibody TECENTRIQ [generic name: atezolizumab (genetical recombination)] to the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of unresectable, locally advanced or metastatic breast cancer and a new 840 mg formulation (Press release, Chugai, DEC 21, 2018, View Source [SID1234532239]).

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This application is based on the results from a global phase III clinical study (IMpassion130 study). The IMpassion130 study is a multicenter, double-blind, randomized, placebo-controlled, global clinical study evaluating the efficacy, safety, and pharmacokinetics of TECENTRIQ in combination with nab-paclitaxel (albumin-bound) compared with nab-paclitaxel alone (albumin-bound) in patients with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer. Co-primary endpoints of this study are progression-free survival per investigator assessment and overall survival. Both primary endpoints are assessed in intent-to-treat (ITT) and PD-L1 positive population. Secondary endpoints are objective response rate, duration of response, and time to deterioration in Global Health Status/Health-Related Quality of Life.

"Triple-negative breast cancer is an aggressive disease with poor prognosis and high unmet medical needs," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "TECENTRIQ is the first immune checkpoint inhibitor whose efficacy against triple-negative breast cancer has been confirmed. We are committed to deliver atezolizumab to patients as early as possible, and contribute to the realization of better treatment in Japan."

[Reference information]
Roche’s Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer (Roche media release dated October 20, 2018)
View Source

About Triple-Negative Breast Cancer
In Japan, 86,500 women (2018 predicted value) are estimated to be afflicted with breast cancer each year. 14,285 women in Japan (2017 predicted value) die as a result of the disease. Triple-negative breast cancer accounts for 15% of all breast cancer cases and, is more common in women under the age of 50, compared with other forms of breast cancer. Triple-negative breast cancer is defined by the lack of expression of hormone receptors (estrogen and progesterone receptors) and the overexpression of human epidermal growth factor receptor 2 (HER2). In general, triple-negative breast cancer has a high tumor-proliferative capacity and shorter overall survival, compared with other forms of breast cancer.

About TECENTRIQ
In Japan, TECENTRIQ was approved for "unresectable and advanced/recurrent non-small cell lung cancer" in January, 2018 and launched in April. Applications for additional indications of first-line treatment of small cell lung cancer were filed, and first-line treatment of non-small cell lung cancer were approved in December, 2018.

References

Cancer Registry and Statistics. Cancer Information Service, National Cancer Center Japan from: View Source Accessed October 2018
Abramson VG et al. Subtyping of triple-negative breast cancer: implications for therapy. Cancer. 2015;121(1):8-16. 3.
Cancer Center. Triple negative breast cancer risk factors. [Internet; cited 2018 May 24]. Available from: View Source Accessed October 2018.
Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627-636.
American Cancer Society. Breast Cancer Facts & Figures 2013-2014
Lehmann BD et al. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. J Clin Invest. 2011;121(7):2750-67.

On December 21, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Iovance Biotherapeutics, DEC 21, 2018, View Source;p=irol-newsArticle&ID=2381465 [SID1234532223]). Details of the presentation are as follows:

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Presenter: Maria Fardis, Ph.D., President and Chief Executive Officer
Date: Thursday, Jan. 10, 2019
Time: 10:30 a.m. PST
Webcast: A live and archived audio webcast of the presentation will be available in the "Investors" section at www.iovance.com.

On December 21, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, "TECENTRIQ Intravenous Infusion 1200 mg" (generic name: atezolizumab [genetical recombination]) from the Ministry of Health, Labour and Welfare (MHLW) for additional dosing for the treatment of "previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) (Press release, Chugai, DEC 21, 2018, View Source [SID1234532240])."

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"Following the approval for previously treated NSCLC obtained in January, 2018, we are pleased to gain another approval which enables us to provide a new treatment option as an initial treatment for patients with advanced or recurrent non-squamous NSCLC," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management unit. "Chugai has been conducting five clinical studies in NSCLC in Japan to evaluate TECENTRIQ alone or in combination with other drugs. We are committed to work closely with Roche to provide patients with as many new treatment options as possible to meet their needs."

This approval is based on results from the Phase III IMpower150 study, which showed that TECENTRIQ in combination with AVASTIN and chemotherapy helped people live significantly longer, compared to AVASTIN and chemotherapy. The safety profile of the TECENTRIQ combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.

[Reference]
Press release issued by Roche on May 17, 2018
Phase III IMpower150 study showed Roche’s Tecentriq and Avastin plus carboplatin and paclitaxel helped people with a specific type of metastatic lung cancer live significantly longer compared to Avastin plus carboplatin and paclitaxel
View Source

In Japan, the annual prevalence of lung cancer is estimated to be approximately 134,000 in 2015 (male: 91,000, female: 43,000). The annual mortality of lung cancer, the leading cause of cancer death in Japan, is approximately 77,000 (male: 55,000, female: 22,000; predicted figure for 2015).*

As a top pharmaceutical company in 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 part has been newly added and changed.

Product name
TECENTRIQ Intravenous Infusion 1200 mg
Generic name
atezolizumab (genetical recombination)
Indications
Unresectable, advanced or recurrent non-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 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.
Drug price
TECENTRIQ Intravenous Infusion 1200 mg JPY 625,567/per vial
Conditions for approval
1. A risk management plan should be created and appropriately implemented.
2. Because the number of participants in Japanese clinical trials was very limited, post-marketing drug use surveillance of all patients receiving TECENTRIQ treatment should be conducted until data for a certain number of patients have been accumulated, in order to understand background information on people using TECENTRIQ as well as to collect safety and efficacy data on TECENTRIQ promptly, and take necessary measures for the appropriate use of TECENTRIQ.
About TECENTRIQ
In Japan, TECENTRIQ was approved for the indications on "unresectable advanced or recurrent NSCLC" in January, 2018 and was launched in April. In addition, a supplementary application for the first-line treatment of small cell lung cancer was filed in December 7, 2018.

On December 21, 2019 Helix BioPharma Corp. (TSX, FSE: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a third tranche of a private placement financing for gross proceeds of CAD700,800 (Press release, Helix BioPharma, DEC 21, 2018, View Source [SID1234533056]). Helix closed the first and second tranches of the private placement on December 6, 2018 and December 20, 2018 for gross proceeds of CAD871,200 and CAD342,000, respectively. The Company expects to complete a final tranche of the private placement financing before the end of December.

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The terms of the placement are for the purchase of units at $1.20 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $1.50 and have an expiry of five years from the date of issuance. Helix intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

On December 21, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported that its Phase 2 TRAXAR trial evaluating TRC105 in combination with Inlyta (axitinib) in patients with advanced or metastatic renal cell carcinoma did not meet the primary endpoint of improving progression free survival (PFS) in the intent to treat population compared to Inlyta monotherapy (Press release, Tracon Pharmaceuticals, DEC 21, 2018, View Source [SID1234532224]).

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Prespecified statistical analyses of PFS according to expression of two plasma biomarkers, TGFβ receptor III and osteopontin, also did not achieve statistical significance. The safety profile observed in TRAXAR was consistent with that observed in previously reported studies of TRC105 in combination with VEGF inhibitors.

TRACON will work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

"We are disappointed that TRC105 in combination with Inlyta did not demonstrate clinically meaningful efficacy in patients with advanced or metastatic renal cell carcinoma. Importantly, data from TRAXAR, including analyses of an extensive biomarker panel, will contribute to our understanding of the role of endoglin inhibition in combination with VEGF inhibitors, and may inform our broad TRC105 clinical development program," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We remain focused on the interim analysis to determine the final sample size of the Phase 3 TAPPAS trial of TRC105 and Votrient in angiosarcoma, which is expected in the first quarter of 2019."

About the TRAXAR trial in Advanced or Metastatic Renal Cell Carcinoma

The TRAXAR trial compared treatment with TRC105 and Inlyta to treatment with single agent Inlyta in 150 patients with advanced or metastatic renal cell carcinoma with a clear cell component. Patients were randomized in equal numbers and the primary endpoint was progression free survival by RECIST 1.1. Key secondary endpoints included objective response rate, safety and tolerability.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.