On September 5, 2018 Iovance Biotherapeutics, Inc presented the Corporate Presentation (Presentation, Iovance Biotherapeutics, SEP 5, 2018, View Source [SID1234529316]).

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On September 5, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported new interim poziotinib data from the MD Anderson Phase 2 non-small cell lung cancer (NSCLC) study which appeared in an online abstract as part of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (Press release, Spectrum Pharmaceuticals, SEPT 5, 2018, View Source [SID1234529294]). The interim results, which include data from the EGFR cohort and, for the first time, the HER2 cohort, are preliminary and based on data through May 3, 2018. More robust and updated data will be presented in an oral session on September 24 at the conference in Toronto, Canada.

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"These results add to a growing body of evidence supporting the role of poziotinib in patients with EGFR and HER2 exon 20 mutations, and are a real advance for these patients for whom no targeted therapies have been effective so far," said John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center. "I am highly encouraged by these results and the evolution of poziotinib data. Our study is the single largest data set in this high unmet need patient population and I am excited to present updated data during an oral session at the IASLC World Conference on Lung Cancer."

Data appearing in the abstract were current as of May 3, 2018. 40 patients of the 50 patient EGFR cohort had data available for the efficacy analysis. In the 40 patients, poziotinib continued to show robust efficacy with an objective response rate (ORR) of 58% in this heavily pre-treated population. Median progression free survival (PFS) was 5.6 months (95%-CI 5.06-NA). The disease control rate was 90%. In the HER2 cohort the ORR was 50% and the disease control rate was 83%. The most common adverse events were skin-rash (27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients required dose reduction to 12mg, while 17.5% of patients required dose reduction to 8mg. Updated data will be presented at the conference and will include data into September.

"We are thrilled with the data presented in the abstract and look forward to a more robust data set on September 24th," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Additionally, we believe the treatment potential of poziotinib may go well beyond the previously treated lung cancer setting. We are actively expanding the poziotinib clinical program to explore poziotinib in new areas including first-line treatment of NSCLC, treatment of other solid tumors with EGFR or HER2 mutations, and combination therapies."

Spectrum Pharmaceuticals will be hosting a live webcast on September 24 following the oral presentation.

Abstract: A Phase II Trial of Poziotinib in EGFR and HER2 exon 20 Mutant Non-Small Cell Lung Cancer

Background

Insertions/mutations in exon 20 of EGFR and HER2 occur in ~1% and ~3% of all lung adenocarcinomas, respectively. These alterations are characterized by primary resistance to approved tyrosine kinase inhibitors (TKIs) with response rates of <12%. We have previously shown that exon 20 insertions restrict the size of the drug-binding pocket, limiting binding of large inhibitors. However, poziotinib can circumvent these steric changes and is a potent inhibitor of EGFR and HER2 exon 20 mutants (Robichaux et al. Nat Med). Herein, we report the results of an investigator-initiated study of poziotinib in EGFR and HER2 exon 20 mutant NSCLC (NCT03066206).

Methods

Patients ≥18yrs with locally advanced/metastatic NSCLC bearing mutations/insertions in EGFR or HER2 exon 20 (except EGFR T790M) were eligible. Unlimited prior systemic and targeted therapies were permitted. Poziotinib 16mg PO daily was administered until progression, death, or withdrawal. The primary endpoint was objective response rate (ORR) based on RECIST v1.1. Response was evaluated every eight weeks. A Bayesian design was used with a plan to enroll patients in cohorts of 10 and to terminate the study if ORR was ≤20%. Secondary endpoints included disease control rate (DCR); progression-free survival (PFS); overall survival; and safety.

Results

As of May 3, 2018, the planned EGFR cohort of 50 patients was fully enrolled, and 40 patients were evaluated for response. Median age was 55yrs (range 29-78). 65.1% of patients had received at least two prior lines of therapy for metastatic disease. 60% of patients had ≥grade 3 adverse events; most common were skin-rash (27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients required dose reduction to 12mg, while 17.5% of patients required dose reduction to 8mg. One patient stopped the treatment due to grade 3 skin rash. The ORR at eight weeks was 58% (95%-CI 40.9-73.0) and the DCR was 90% (95%-CI 76.3-97.2). Among 23 patients who achieved partial response, 15 responses were confirmed, five responses were unconfirmed, and three patients are pending confirmation. Responses were observed in 8/13 (62%) patients that were previously treated with TKI. Median PFS was 5.6mo (95%-CI 5.06-NA). Furthermore, 13 patients were enrolled in the HER2 cohort. Observed toxicities were similar to the EGFR cohort except one case of grade 5 pneumonitis, assessed to be possibly drug related. Twelve patients were evaluated for response with an ORR of 50% (95% CI 21.1-78.9) at eight weeks and a DCR of 83%.

Conclusion

The trial exceeded the stopping boundary of ORR of 20%. In a heavily pre-treated population with EGFR and HER2 exon 20 mutant NSCLC, poziotinib provides a high ORR, an encouraging PFS, and a manageable toxicity profile.

Conference Call Details:

Monday, September 24, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 1993267
International: (973) 796-5077, Conference ID# 1993267

The conference call will also be webcast live. To access the webcast and additional documents related to the call, please visit the Investor Relations page of the Spectrum Pharmaceuticals website at View Source

For interested individuals unable to join the call, a replay will be available from September 24, 2018 @ 7:00 p.m. ET/4:00 p.m. PT through October 1, 2018, until 7:30 p.m. ET/4:30 p.m. PT.

Domestic Replay Dial-In: (855) 859-2056, Conference ID# 1993267
International Replay Dial-In: (404) 537-3406, Conference ID# 1993267

About Poziotinib

Poziotinib is a novel, orally available Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, 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. Spectrum received an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize worldwide excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.

The poziotinib NSCLC clinical program for patients with EGFR or HER2 exon 20 insertion mutations currently consists of a Phase 2 investigator-initiated study at The University of Texas MD Anderson Cancer Center and a Phase 2 pivotal, Spectrum-sponsored, multi-center, global study (ZENITH20) with active sites in the United States and future centers planned in Canada and Europe.

On September 5, 2018 SpringWorks Therapeutics, a clinical-stage rare disease and oncology company focused on sourcing and developing innovative treatments for underserved patient populations, reported that the company’s Board of Directors has appointed Saqib Islam as chief executive officer (Press release, SpringWorks Therapeutics, SEPT 5, 2018, View Source [SID1234529295]). Mr. Islam, who previously served as chief financial and chief business officer at SpringWorks Therapeutics, will also join the Board of Directors.

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"After a thorough and thoughtful search process, we are pleased to appoint Saqib as SpringWorks Therapeutics’ inaugural CEO and a member of our Board. Saqib has demonstrated exceptional leadership in building SpringWorks and brings to bear a broad set of skills and experiences that will enable our future success. With Saqib as CEO, we are extremely well positioned to execute on our multiple initiatives to deliver promising science to underserved patient populations," said Daniel S. Lynch, Executive Chairman of SpringWorks Therapeutics.

Mr. Islam has led SpringWorks Therapeutics’ key business operations and strategic corporate planning activities since the company’s launch in September 2017. He joined SpringWorks Therapeutics from Moderna Therapeutics, where he served as chief business officer and oversaw global strategic planning, corporate development and business development. Prior to Moderna, Mr. Islam served as executive vice president, chief strategy and portfolio officer at Alexion Pharmaceuticals. Mr. Islam has over 25 years of international business management experience and an extensive background in the healthcare banking sector, having held managing director positions in the investment banking divisions of Morgan Stanley and Credit Suisse Securities. He received a bachelor’s degree from McGill University and a J.D. from Columbia Law School, where he was a Harlan Fiske Stone Scholar.

"I joined SpringWorks Therapeutics because I saw a unique opportunity to build a company centered around the ambition of developing transformative medicines for severe diseases that do not currently have a cure, starting with our two lead development programs for patients with desmoid tumors and neurofibromatosis type 1, two rare and devastating tumors," said Mr. Islam. "I am honored to have the opportunity to lead SpringWorks and am very pleased to have assembled an experienced management team comprised of leaders who share our mission-driven approach to serving patients, each of whom will play a critical role in advancing and building upon the great work that has been done thus far."

Experienced Leadership Team

SpringWorks Therapeutics has built a team of highly talented executives with deep industry experience and a proven track record in their respective areas of expertise.

Jens Renstrup, M.D., MBA, Chief Medical Officer: Dr. Renstrup is responsible for developing and driving execution of the clinical development programs and oversees medical affairs. He has extensive experience building medical affairs organizations at pharmaceutical and biotech companies, shaping early- to late-stage development pipelines, and a proven track record accelerating time to market and new drug approvals. Prior to joining SpringWorks Therapeutics, Dr. Renstrup served as senior vice president and head of global medical affairs at Alexion Pharmaceuticals and vice president and head of global medical affairs at GSK Vaccines. Earlier in his career, Dr. Renstrup served in progressive leadership positions at Merck & Co, and he started his career at IPSEN Scandinavia A/S. Dr. Renstrup holds an M.D. and specialist medical degree in anesthesiology and intensive care medicine from the University of Copenhagen, as well as an MBA from the Copenhagen Business School.
Badreddin Edris, Ph.D., Chief Business Officer: Dr. Edris is responsible for corporate strategy, business development and capital formation for the company. His professional experience spans private and public equity investing, company formation and operations, corporate and business development, and strategic and product planning in the biotechnology industry. Prior to joining SpringWorks Therapeutics, Dr. Edris was an investment and operating professional on the private equity team at OrbiMed, where he was involved in deal sourcing, evaluation and execution, as well as post-investment strategic and operational support for biotechnology companies across a range of therapeutic areas and stages of development. Dr. Edris also co-founded and held operating roles at two OrbiMed portfolio companies, Silverback Therapeutics (where he was chief business officer) and Edgewise Therapeutics (where he was chief operating officer). Before OrbiMed, Dr. Edris was a management consultant at Bain & Company, where he collaborated with global pharmaceutical and biotechnology companies on a range of strategic and operational projects. Dr. Edris received his Ph.D. in genetics from Stanford University, where he was an NSF research fellow.
L. Mary Smith, Ph.D., Senior Vice President, Clinical Research and Development: Dr. Smith is responsible for designing and running the clinical development programs for SpringWorks Therapeutics. Prior to joining SpringWorks Therapeutics, Dr. Smith was the executive vice president of gene therapy at Bamboo Therapeutics, a wholly owned subsidiary of Pfizer, where she led several key gene transfer programs for rare genetic diseases. Prior to joining Bamboo, Dr. Smith was the vice president of product development at United Therapeutics, with responsibility for biological development in oncology, as well as regenerative medicine and virology. Dr. Smith holds a Ph.D. in microbiology/immunology from the University of New Hampshire and received her post-doctoral training at Emory University.
Michael Greco, J.D., General Counsel and Secretary: Mr. Greco is responsible for the company’s legal and compliance functions. He is an experienced legal executive who previously served as senior vice president of law and corporate secretary for Alexion Pharmaceuticals. He joined Alexion shortly prior to the launch of Alexion’s first and lead product and during his tenure assumed positions of increasing responsibility in the company’s legal department. In his most recent role, he was responsible for overseeing corporate governance initiatives, public reporting and securities compliance and corporate transactions. He was also responsible for managing the legal department’s corporate, R&D, business development and employment law legal teams. Prior to Alexion, Mr. Greco was a corporate attorney at Wiggin and Dana LLP and Bingham McCutchen LLP (now Morgan Lewis). Before law school, Mr. Greco served in the U.S. Army Corps of Engineers. Mr. Greco received a J.D. from Suffolk University Law School and a Bachelor of Science degree from the United States Military Academy, West Point.
Lisa Sinclair, Head of Program and Alliance Management: Ms. Sinclair is responsible for portfolio management and alliance development with the company’s biopharmaceutical partners, including the collaboration with Pfizer. Ms. Sinclair brings significant experience in driving the delivery of medicines from IND through approval in top-tier global biopharmaceutical companies and has a proven track record of accelerating medicines to key decision points in rare diseases. Prior to joining SpringWorks Therapeutics, she served as vice president of R&D strategy, portfolio and project management at Alexion Pharmaceuticals, where she led the development and execution of the five-year R&D strategic plan across multiple disease franchises and built portfolio and project management capabilities that supported pipeline speed, growth and value. Prior to Alexion, Ms. Sinclair was vice president of R&D portfolio and performance at AstraZeneca, where she was accountable for transforming global portfolio management across R&D and implemented R&D therapeutic area planning, portfolio prioritization, resource management, and performance metrics and analytics. Prior to AstraZeneca, she held various roles of increasing responsibility at Pfizer. Ms. Sinclair received a bachelor’s degree in business from the University of Vermont.
Kim Diamond, Head of Communications and Investor Relations: Ms. Diamond is responsible for the company’s internal and external communications strategy and investor relations. She has significant experience across the biopharmaceutical industry, including an established track record of launching rare disease therapies and broad therapeutic area expertise in oncology, hematology, nephrology, neurology and metabolic disorders. Prior to joining SpringWorks Therapeutics, Ms. Diamond served as executive director of corporate communications at Alexion Pharmaceuticals, where she was responsible for global external communications, including company reputation and branding, global product launches, and digital communications. Prior to Alexion, Ms. Diamond was director of corporate communications at OSI Pharmaceuticals, and she also held roles of increasing responsibility in the healthcare practice of Edelman earlier in her career. Ms. Diamond received a bachelor’s degree from Middlebury College.

On September 5, 2018 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Merck & Co., Inc., Kenilworth N.J., U.S.A., known as MSD outside of the United States and Canada, reported that the China National Medical Products Administration (NMPA) approved the kinase inhibitor LENVIMA (lenvatinib) as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (Press release, Eisai, SEPT 5, 2018, View Source [SID1234529337]). In China, the application of LENVIMA was submitted in October 2017, and was designated for Priority Review by the NMPA due to LENVIMA’s significant clinical benefit compared to existing treatments, leading to approval in approximately 10 months. This approval marks the first for LENVIMA in China, where the incidence of HCC is high,1 and the first new systemic therapy approved for the first-line treatment of unresectable HCC in China in ten years.1

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The approval was based on results from the REFLECT study (Study 304),2 an open-label, Phase 3 trial where LENVIMA demonstrated a treatment effect on overall survival (OS)*1 by statistical confirmation of non-inferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC. LENVIMA demonstrated statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS)*2, time to progression (TTP)*3 and objective response rate (ORR)*4. In a subpopulation analysis of 288 patients in the study from the greater Chinese region (mainland China, Hong Kong and Taiwan), LENVIMA demonstrated efficacy based on non-inferiority of OS compared to sorafenib, with improvements also observed in PFS, TTP and ORR3. Approximately 80% of patients in the subpopulation were living with HCC resulting from chronic hepatitis B virus (HBV), which has high unmet medical need. For these patients, LENVIMA demonstrated non-inferiority based on OS compared with sorafenib, thereby demonstrating the effect of LENVIMA in patients with HCC resulting from HBV. (For the detailed data, please refer to "Notes for Editors" below.)

In the China package insert, the five most common adverse reactions observed in patients treated with LENVIMA were hypertension (45%), fatigue (44%), diarrhea (39%), decreased appetite (34%) and decreased weight (31%), which is consistent with the known side-effect profile of LENVIMA.

Liver cancer is the second leading cause of cancer-related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. Additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions. Specifically, in China, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide.1 HCC accounts for 85% to 90% of primary liver cancer cases. Unresectable HCC, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.

Since the initial launch, more than 10,000 patients have been treated with LENVIMA. Today, LENVIMA is approved as a treatment for refractory thyroid cancer in over 50 countries including the United States, Japan, in Europe and Asia, and as combination with everolimus as a second-line treatment for renal cell carcinoma (RCC) in over 45 countries including the United States and in Europe. For HCC, LENVIMA was approved for use in Japan in March 2018, and in the United States and Europe in August 2018. In Japan, approximately 3,000 HCC patients have been treated with LENVIMA since approval of this indication.

*1 Overall Survival (OS): The time period from the commencement of cancer treatment up until death by any cause. Whether the cause of death is cancer or not is not taken into consideration for this variable.

*2 Progression Free Survival (PFS): PFS is the objectively confirmed time from the commencement of cancer treatment to the date of disease progression, or date of death from any cause, whichever occurs first.

*3 Time To Progression: TTP is the objectively confirmed time from the commencement of cancer treatment to the date of disease progression. Unlike PFS, TTP does not consider death from any cause.

*4 Objective Response Rate (ORR): ORR is the combined proportion of patients whose tumor was eliminated (complete response) and whose tumor was reduced by over 30% in size (partial response) as verified by imaging assessment.

About the REFLECT Trial (Study 304) 2

REFLECT was a large (n=954) Phase 3, randomized, multicenter, open-label trial conducted by Eisai to compare the efficacy and safety of LENVIMA versus sorafenib as a first-line systemic treatment in patients with unresectable HCC. Patients at 154 trial sites in 20 countries were randomized to receive LENVIMA 12 mg or 8 mg once a day depending on body weight (≥60 kg or <60 kg, respectively) (n=478) or sorafenib 400 mg twice a day (n=476). Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint of this study was OS, tested first for non-inferiority to sorafenib, then for superiority. The key secondary efficacy endpoints of this study included PFS, TTP and ORR, tested for superiority to sorafenib.

In the China package insert, REFLECT showed that LENVIMA achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to sorafenib. Patients treated with LENVIMA experienced a median OS of 13.6 months compared to 12.3 months with sorafenib (Hazard Ratio [HR]: 0.92; 95% Confidence Interval [CI]: 0.79-1.06). Patients randomized to the LENVIMA arm did not have a statistically significant improvement in OS compared to those in the sorafenib arm. In addition, LENVIMA showed statistically significant superiority and clinically meaningful improvements in the secondary efficacy endpoints of PFS, TTP and ORR, as confirmed by a blinded independent imaging review:

• Median PFS was doubled with LENVIMA compared to sorafenib: 7.3 months versus 3.6 months (HR: 0.64; 95% CI: 0.55–0.75; p<0.00001) per blinded independent imaging review based on mRECIST criteria.
• Median TTP was doubled with LENVIMA compared to sorafenib: 7.4 months versus 3.7 months (HR: 0.60; 95% CI: 0.51–0.71; p<0.00001) per blinded independent imaging review based on mRECIST criteria.
• LENVIMA showed nearly 3.5 times the ORR of sorafenib: 40.6% (95% CI: 36.2-45.0) versus 12.4% (95% CI: 9.4-15.4) per blinded independent imaging review based on mRECIST criteria (odds ratio 5.01, 95% CI: 3.59-7.01; p<0.00001).

About the Subpopulation Analysis of Patients from the Greater Chinese Region3

The results of subpopulation analysis of patients from the greater Chinese region3 were based on 288 patients out of the 954 HCC patients who participated in the REFLECT study. In this subpopulation analysis, median OS was 15.0 months for LENVIMA versus 10.2 months for sorafenib (HR: 0.73; 95% CI: 0.55-0.96; nominal p=0.02620). Independent imaging review based on mRECIST criteria revealed the following results: PFS (LENVIMA 8.4 months versus sorafenib 3.6 months in median [HR: 0.47; 95% CI: 0.35-0.64; nominal p<0.00001]), TTP (LENVIMA 9.2 months versus sorafenib 3.6 months in median [HR: 0.45; 95% CI: 0.33-0.62; nominal p<0.00001]) and ORR (LENVIMA 43.8% versus sorafenib 13.2% [odds ratio 5.14; 95% CI: 2.84-9.31; nominal p<0.00001]).

Additionally, of the 288 patients in the subpopulation, approximately 80% (n=242) were living with HCC resulting from HBV. An analysis of these patients revealed the following results for OS: LENVIMA (n=123) 14.9 months versus sorafenib (n=119) 9.9 months in median (HR: 0.72; 95% CI: 0.53-0.97).

About Unresectable Hepatocellular Carcinoma (HCC)

Liver cancer is the second leading cause of cancer-related deaths and is estimated to be responsible for 750,000 deaths per year globally. Additionally, 780,000 cases are newly diagnosed each year.2 There is a large regional difference, with about 80% of new cases occurring in Asian regions, including China and Japan. HCC accounts for 85% to 90% of primary liver cancer cases. HCC is associated with chronic liver disease, in particular cirrhosis. Major causes of cirrhosis include hepatitis B virus and hepatitis C virus. However, according to a recent investigation, non-B/non-C HCC is on the rise. Surgery is the first option for treatment, but for patients with unresectable HCC who are not amenable for potentially curative therapeutic interventions, which include liver transplant, surgical resection and tumor ablation (typically radiofrequency ablation or cryotherapy), or who are not suitable for transarterial chemoembolization (TACE), treatment options are limited and the prognosis is very poor.

About LENVIMA (lenvatinib mesylate)

Discovered and developed in-house by Eisai, LENVIMA is an orally administered kinase inhibitor with a novel binding mode that selectively inhibits the multi activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRα; KIT; and RET) involved in tumor angiogenesis, tumor progression and modification of tumor immunity.

Currently, Eisai has obtained approval for LENVIMA as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, in Europe and Asia. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a second-line treatment for RCC in over 45 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx for RCC.

In addition, LENVIMA has been approved as a treatment for hepatocellular carcinoma in Japan, the United States, Europe and South Korea. Eisai has submitted applications for an indication covering hepatocellular carcinoma in Taiwan (December 2017), as well as in other countries.

It is important to note that the dose for LENVIMA for patients with unresectable HCC is based on the patient’s weight (12 mg for patients weighing 60 kilograms or more, 8 mg for patients weighing less than 60 kilograms); the recommended dosage and dose adjustments are described in the full prescribing information.

On September 05 2018, Roche reported that it was notified by the U.S. Food and Drug Administration (FDA) that the review period for the supplemental Biologics License Application (sBLA) for TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) has been extended by three months (Press release, Hoffmann-La Roche, SEP 5, 2018, View Source [SID1234529354]). The extension allows the FDA time to review additional information requested in support of the sBLA. FDA determined that the submission of this information constituted a major amendment to the sBLA resulting in this extension of the PDUFA goal date. The FDA is expected to make a decision on approval by December 05, 2018. In May 2018, TECENTRIQ in combination with Avastin, carboplatin and paclitaxel was granted Priority Review from the FDA for the initial treatment of people with metastatic non-squamous NSCLC based on results from the Phase III IMpower150 study.

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About NSCLC
Lung cancer is the leading cause of cancer death globally.[1] Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[2] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.[3]

About TECENTRIQ
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 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 has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.

TECENTRIQ is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About Avastin (bevacizumab)
Avastin is a biologic cancer treatment approved across several types of cancers including advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and recurrent glioblastoma. Avastin is approved in combination with chemotherapy for the first-line treatment of advanced NSCLC and, to-date, has helped over 500,000 patients lead longer lives. Avastin is considered a standard of care for the first-line treatment of advanced NSCLC and has been proven to significantly extend overall survival (OS). Avastin is currently approved in combination with any platinum-based chemotherapy in Europe, and with paclitaxel/carboplatin in the US, in first-line non-squamous NSCLC, based on results of the pivotal Phase III E4599 study. Avastin was the first medicine to help people with previously untreated advanced, non-squamous NSCLC live longer (OS) than one year when added to chemotherapy.

About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support combining TECENTRIQ and Avastin. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.