On September 6, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that is developing poziotinib in non-small cell lung cancer (NSCLC) EGFR exon 20 mutations and beyond (Press release, Spectrum Pharmaceuticals, SEP 6, 2019, View Source [SID1234539341]). New clinical data from the poziotinib Phase 2 investigator-initiated trial in NSCLC EGFR exon 20 mutations, conducted by the University of Texas MD Anderson Cancer Center will be presented during the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer taking place in Barcelona, Spain from September 7-10, 2019.

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"There continues to be investigator interest in poziotinib’s unique characteristics to address NSCLC mutations, including exon 20 and other mutations, which have limited or no treatment options," said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. "The data presented at this conference by our scientific collaborators at MD Anderson further expands the body of evidence supporting poziotinib’s role in lung cancer and helps us gain new insights into its full potential."

Abstracts of interest include:

Activity of Poziotinib and Other 2nd-Gen Quinazoline EGFR TKIs in Atypical Exon18 and Acquired Osimertinib Resistance Mutants
Abstract P1.14-08, Targeted Therapy Track, poster presentation, Sunday, September 8, 9:45 am – 6:00 pm CET in Fira De Barcelona, Gran Via, Exhibit Hall
Identification of Mechanisms of Acquired Resistance to Poziotinib in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer (NSCLC)
Abstract MA09.03, Targeted Therapy Track, mini oral session, Sunday, September 8, 3:25-3:30 pm CET at Fira De Barcelona, Gran Via, Room Melbourne (1991)
Full abstracts can be found by visiting View Source

"NSCLC patients with exon 20 insertion mutations have a poor prognosis and very limited treatment options. We are diligently developing poziotinib and look forward to topline results from cohort 1 of our Spectrum-sponsored Phase 2 study in the fourth quarter," said Joe Turgeon, President and CEO of Spectrum Pharmaceutical.

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR (HER1) as well as HER2 and HER4. Importantly this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The full poziotinib targeted therapy clinical program is focused on four development areas for EGFR and HER2 mutations, including previously treated NSCLC, first-line NSCLC, treatment of other solid tumors and combination therapy.

Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several trials in multiple solid tumors.

On September 6, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that its Chief Executive Officer, Jed Latkin, will present a corporate overview of the Company at the H.C. Wainwright 21st Annual Global Investment Conference, being held September 8-10, 2019 in New York, New York (Press release, Navidea Biopharmaceuticals, SEP 6, 2019, https://ir.navidea.com/news/detail/326/navidea-biopharmaceuticals-to-present-at-the-h-c-wainwright-21st-annual-global-investment-conference [SID1234539340]).

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Conference Presentation Details

When:

September 9, 2019, 3:50-4:15 p.m.

Where:

Lotte New York Palace Hotel

Room:

Holmes II (4th floor)

Webcast Link:

View Source

A replay of the webcast will be available for 90 days.

On September 6, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for expanded use of FoundationOne CDx Cancer Genomic Profile, a next-generation sequencing based program, as a companion diagnostic for ROS1/TRK inhibitor, Rozlytrek Capsules 100 mg and 200 mg (generic name: entrectinib) for the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC) (Press release, Chugai, SEP 6, 2019, View Source [SID1234539339]).

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The filing aims to expand the program for use as a companion diagnostic to identify people that could potentially benefit from Rozlyterk for the treatment of ROS1 fusion-positive locally advanced or metastatic NSCLC by detecting the ROS1 gene fusions using next-generation sequencer. ROS1 fusion gene is an abnormal gene that can be formed by fusing the ROS1 gene and other genes (CD74, etc.) as a result of chromosomal translocation for some reason. The ROS1 fusion kinase made from ROS1 fusion gene is considered to promote cancer cell proliferation.2 The ROS1 fusion gene is prevalent in about 1-2% of non-small cell lung cancer, among them, it is more expressed in adenocarcinoma. 1, 2

Rozlytrek was granted regulatory approval by MHLW for the treatment of NTRK fusion gene positive advanced and recurrent solid tumors on June 18, 2019 and the drug has been launched on September 4. An application has been filed with the MHLW for the extended indication of ROS1 fusion-positive NSCLC on March 15, 2019.

FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device developed by Foundation Medicine Inc. The product detects substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program was approved to use as a companion diagnostic for 14 molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

[Notes]
A press release issued on March 15, 2019: Chugai Files a New Drug Application for a ROS1/TRK Inhibitor Entrectinib for the Treatment of ROS1 Fusion-Positive Non-Small Cell Lung Cancer
View Source

About Rozlytrek
Rozlytrek is an oral medicine for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 or ROS1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. FDA has approved Rozlytrek for people with ROS1-positive, metastatic NSCLC and NTRK gene fusion-positive solid tumors. Rozlytrek was granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

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

References

Davies KD, Doebele RC. Clin Cancer Res. 2013;19(15):4040-4045. PMID: 23719267
Bergethon K, Shaw AT, Ou SH, et al. J Clin Oncol. 2012;30(8):863-870. PMID: 22215748

On September 6, 2019 Taiho Pharmaceutical Co., Ltd. reported that the China National Medical Products Administration (NMPA) has approved the anticancer agent TAS-102 (brand name in Japan "LonsurfⓇ", trifluridine/tipiracil (FTD/TPI), development code TAS-102) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, in addition, might be treated or not able to be treated by an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy (Press release, Taiho, SEP 6, 2019, View Source [SID1234539338]).

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This approval is based on the results of the Phase III TERRA study on patients with refractory mCRC in Asia (China, South Korea, and Thailand). The study met the primary efficacy endpoint of statistically prolonging overall survival (OS) in patients with unresectable advanced or recurrent colorectal cancer. The drug appeared to be generally well tolerated and its toxicities were consistent with what has been previously reported.

With this latest approval, Taiho Pharmaceutical expects that Lonsurf will make a broader contribution to patients and medical institutions as a new treatment option for patients with colorectal cancer.

About the TERRA study
The TERRA study was a randomized, double-blind, placebo-controlled Phase III comparison study evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The study enrolled 406 patients who received at least two prior regimens of standard chemotherapies for mCRC and were refractory or intolerant those chemotherapies. The study was conducted in China, South Korea, and Thailand. Patients were randomly assigned to receive either TAS-102 or placebo in order to investigate the efficacy of TAS-102. The primary objective of the TERRA study was improvement in OS versus placebo. The study was conducted under the leadership of principal researchers in China, South Korea, and Thailand. Results from TERRA study were presented at ESMO (Free ESMO Whitepaper) 2016 Congress and e-published in the Journal of Clinical Oncology in 2017*1.

About Colorectal Cancer
The number of patients with colorectal cancer in China is on the rise. It is the fifth most common cancer cause of death in China after lung cancer, gastric cancer, hepatic cancer, and esophageal cancer. It has been reported that around 250,000 people died of colorectal cancer in China in 2018.*2

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 mCRC refractory to prior therapy.

Taiho Pharmaceutical and Servier*2 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 August 2019, Lonsurf has been approved as a treatment for advanced mCRC in 72 countries and regions worldwide. Lonsurf has been approved as a treatment for metastatic gastric cancer in the United States in February 2019, in Japan in August 2019 and in EU in September 2019.

*1 Xu, J., Kim T., Shen L., et al. Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Trifluridine/Tipiracil (TAS-102) Monotherapy in Asian Patients With Previously Treated Metastatic Colorectal Cancer: The TERRA Study, Journal of Clinical Oncology, 2018; 36(4): 350-358.

*2 WHO International Agency for Research on Cancer. CANCER TODAY. Colorectal cancer: Estimated number of deaths in 2018, China, both sexes, all age

View Source;mode=cancer&mode_population=who&population=900&populations=160&key=asr&sex=0&cancer=39&type=1&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&nb_items=5&group_cancer=1&include_nmsc=1&include_nmsc_other=1#collapse-group-0-3

(Accessed August 22, 2019)

*3 Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes).

On September 6, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved and granted marketing authorisation for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Hoffmann-La Roche, SEP 6, 2019, View Source [SID1234539337]).

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"This approval makes Tecentriq the first cancer immunotherapy available in Europe for the initial treatment of extensive-stage small cell lung cancer, marking an important step forward for patients," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The combination of Tecentriq and chemotherapy has been shown to improve survival compared to the current standard-of-care – an advance that, until now, has been difficult to achieve due to the refractory nature of this disease."

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 versus 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95% CI, 0.62–0.96; p=0.017).1 Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.

Lung cancer is the leading cause of cancer death worldwide2 and SCLC accounts for approximately 15% of all lung cancer cases, with the majority of patients (70%) diagnosed in the "extensive stage", often meaning a poor prognosis.3 SCLC is distinguished from other lung cancer subtypes due to its aggressive nature, rapid growth, and early development of metastatic disease.3

Currently, Roche has nine Phase III lung cancer studies underway evaluating Tecentriq alone or in combination with other medicines across different types of lung cancer. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower133 study
IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve adults with ES-SCLC. The study enrolled 403 people who were randomised equally (1:1) to receive:

Tecentriq in combination with carboplatin and etoposide (Arm A), or
Placebo in combination with carboplatin and etoposide (Arm B, control arm)
During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.

The co-primary endpoints were PFS, as determined by the investigator using RECIST v1.1, and OS in the ITT population.

A summary of the ITT data from the IMpower133 study that support this approval is included below:1

Tecentriq in combination with chemotherapy helped people live significantly longer, compared with chemotherapy alone (OS=12.3 versus 10.3 months; HR=0.70, 95% CI: 0.54-0.91, p=0.0069) in the ITT population.
The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95% CI: 0.62–0.96, p=0.017).
Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.
Grade 3–4 treatment-related adverse events occurred in 56.6% of people receiving Tecentriq plus chemotherapy, compared with 56.1% of people receiving chemotherapy alone. The most common adverse reactions (≥20%) in people receiving Tecentriq plus chemotherapy were low white blood cell count (neutropenia; 23%), anaemia (14%), decreased neutrophil count (14%) and thrombocytopenia (10%).
About SCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and SCLC, with SCLC accounting for approximately 15% of all lung cancer cases.3

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy (CIT) that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source