On March 11, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported its financial results and business highlights for the fourth quarter and year ended December 31, 2018 (Press release, Athenex, MAR 11, 2019, View Source;p=RssLanding&cat=news&id=2390797 [SID1234534194]).

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"In 2018, we made substantial progress in advancing our pipeline and expanding our technology platforms in oncology as we work towards building a global biopharmaceutical business," stated Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex. "We are on track to continue this positive momentum in 2019, with the expected completion of our Phase III study of Oraxol in metastatic breast cancer and preparations underway for regulatory filings for KX2-391 in actinic keratosis. We now have a total of 8 product candidates in the clinic, with INDs on 2 further candidates scheduled by mid-year, and we are committed to continuing our strong clinical execution. On the operational front, we continue to build out our commercial infrastructure and global supply chain as we put the plans in place to launch our proprietary products."

Fourth Quarter 2018 and Recent Business Highlights:

Clinical Programs:

KX2-391 ointment in actinic keratosis: Positive topline results from two pivotal Phase III studies were featured in a late breaker session at the 2019 American Academy of Dermatology Annual Meeting
In studies KX01-AK-003 and KX01-AK-004, 44% and 54% of patients, respectively, achieved 100% AK lesion clearance at Day 57. The results were highly statistically significant.
Safety profile of KX2-391 ointment may be an important competitive advantage; adherence to treatment was greater than 99%
Oraxol Phase III studies in metastatic breast cancer: Achieved target enrollment of 360 patients. Topline results are expected to be available in mid-2019
Other Oraxol studies:
Announced positive results from the second cohort of patients in a global Phase Ib clinical trial of Oraxol plus ramucirumab in gastric cancer patients who failed previous chemotherapies. The Oraxol dose is currently being further escalated to 300 mg/m2 in the third cohort of patients and the study is ongoing.
Initiated a Phase I/II clinical study to assess the safety, tolerability and activity of Oraxol in combination with anti-PD1 antibody (pembrolizumab) in patients with advanced solid malignancies.
Initiated a Phase I clinical study of Oraxol in angiosarcomas. Oraxol received Orphan Drug Designation from the U.S. FDA for this indication. Preclinical data to be presented in a poster session at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019

Orascovery platform:
Licensed the rights to develop and commercialize Oradoxel (Oral Docetaxel) in Taiwan, Singapore, and Vietnam to PharmaEssentia.
Announced acceptance of an Investigational New Drug (IND) application for Eribulin ORA, Athenex’s oral version of Eribulin.

TCR-T immunotherapy: Announced positive results from pilot studies conducted in China by Xiangxue Life Sciences in end-stage cancer patients who were treated with T-cell receptor affinity enhancing specific T-cell therapy (TAEST), a form of cancer immunotherapy.
Commercial Business:

Athenex Pharmaceutical Division ("APD") currently markets a total of 28 products with 53 SKUs.
Athenex Pharma Solutions ("APS") currently markets 6 products in total with 16 SKUs.
Commercial platform is planning to launch 12 new products in 2019.
Dunkirk manufacturing facility achieved a significant construction milestone with the steel and concrete work complete and the final beam raised into place.
Financial Results for the Fourth Quarter Ended December 31, 2018

Revenue for the three months ended December 31, 2018 was $21.3 million, as compared to $14.9 million for the three months ended December 31, 2017, an increase of $6.4 million, or 43%. Product sales were $19.0 million and $14.1 million for the three months ended in December 31, 2018 and December 31, 2017, respectively. The increase was primarily attributable to an increase of $3.5 million in API revenue, $3.1 million in 503B revenue, offset by $1.8 million decrease in medical device and CMO revenue. There was a $2.0 million licensing fee revenue in the three months ended December 31, 2018, pursuant to a licensing agreement we entered into with PharmaEssentia, for rights to Oral Docetaxel in certain Asian territories.

Cost of sales for the three months ended December 31, 2018 totaled $14.3 million, as compared to $10.1 million for the three months ended December 31, 2017, an increase of $4.2 million, or 42%. The increase was primarily due to a change in our product mix. As we continue to develop our product portfolio, the gross margin might fluctuate over time.

Research and development expenses for the three months ended December 31, 2018 totaled $20.8 million. Our various clinical programs accounted for the majority of our R&D expenses. The R&D expenses for the three months ended December 31, 2018 were in line with the $20.8 million for the three months ended December 31, 2017.

Selling, general, and administrative expenses for the three months ended December 31, 2018 totaled $11.6 million, as compared to $12.3 million for the three months ended December 31, 2017, a decrease of $0.7 million, or 6%.

Net loss attributable to Athenex for the three months ended December 31, 2018 was $27.1 million, or ($0.41) per diluted share, compared to a net loss of $28.3 million, or ($0.49) per diluted share, in the same period last year.

Financial Results for the Year Ended December 31, 2018:

Revenue for the year ended December 31, 2018 was $89.1 million, as compared to $38.0 million for the year ended December 31, 2017, an increase of $51.1 million, or 134%. The increase was primarily attributable to the $30.0 million license fees related to the collaboration agreement with Almirall. Revenue from product sales also increased from $36.1 million in the year ended December 31, 2017 to $56.4 million in the year ended December 31, 2018. The increase was primarily attributable to an increase in specialty product revenue of $13.2 million, an increase in 503B revenue of $5.1 million, an increase in API revenue of $2.6 million, and an increase in medical device sales of $0.6 million, offset by a decrease in contract manufacturing revenue and other revenue of $1.7 million.

Cost of sales for the year ended December 31, 2018 totaled $47.0 million, as compared to $25.1 million for the year ended December 31, 2017, an increase of $21.9 million, or 87%. The increase in specialty product revenue, 503B revenue, and API revenue increased cost of sales by $15.2 million, $3.7 million, and $3.0 million, respectively.

Research and development expenses for the year ended December 31, 2018 totaled $119.9 million, as compared to $76.8 million for the year ended December 31, 2017, an increase of $43.1 million, or 56%. This increase was primarily due to the advancement of the Company’s clinical pipeline and additional drug licensing fees, and included the following: $18.6 million increase of clinical trial costs with the progression of the Phase 3 trials of KX2-391 Ointment and Oraxol; $15.7 million increase in drug licensing fees primarily due to a $29.5 million non-cash license fee related to the purchase of TCR-T technology in connection with the establishment of Axis Therapeutics Limited, of which $24.5 million related to the fair value of the in-process research and development (IPR&D) and $5.0 million was paid for in the Company’s common stock. This was offset by a decrease in drug licensing fees paid to Hanmi, Gland and Amphastar; a $5.4 million increase of employee salary and benefits, which was primarily attributable to hiring more research and development personnel to support our expanding research and clinical activities, including the expansion of our clinical R&D team in Taiwan; a $2.8 million increase in general product development of 503B products as they were introduced and production was scaled-up to a commercial level and product development of our proprietary products; and a $0.6 million increase in the cost of preclinical studies as research was performed on an oral formulation of Eribulin.

Selling, general, and administrative expenses for the year ended December 31, 2018 totaled $49.0 million, as compared to $46.1 million for the year ended December 31, 2017, an increase of $2.9 million, or 6%. This was primarily due to an increase in operating activities and professional fees and included the following: a $2.9 million increase in professional fees including legal fees related to the launch of 503B products and consulting fees related to the manufacturing facility in Dunkirk, NY; and a $2.2 million increase in other office expenses including property and sales taxes, insurance expenses, rent and utilities, and others. These costs were offset by a decrease in employee compensation of $1.6 million from the stock-based compensation incurred in the prior year in connection with the Company’s IPO and a decrease in marketing costs of $0.6 million.

Net loss attributable to Athenex for the year ended December 31, 2018 was $117.4 million, or ($1.82) per diluted share, compared to a net loss of $131.2 million, or ($2.63) per diluted share, for the year ended December 31, 2017.

Excluding the non-cash license fee of $24.5 million in connection with the establishment of Axis Therapeutics Limited in July 2018, the net loss attributable to Athenex for the year ended December 31, 2018 was $92.9 million, or ($1.44) per diluted share.

The Company had cash, cash equivalents and short-term investments aggregating $107.4 million at December 31, 2018, compared to $51.0 million at December 31, 2017. Based on the current operating plan, the Company expects that its cash, cash equivalents and short-term investments as of December 31, 2018, together with cash to be generated from operating activities, will enable it to fund its operating expenses and capital expenditure requirements through at least the fourth quarter of 2019.

Outlook and Upcoming Milestones:

Clinical Platforms:

Complete third cohort of patients for Oraxol with ramucirumab study in gastric cancer.
Presentation of preclinical data for Oraxol in angiosarcomas at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 3, 2019.
Expect to file INDs for TCR-T candidates and Pegtomarginase by mid-2019.
Presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, May 31 – June 4, 2019
Top line results from Phase 3 trial of Oraxol in metastatic breast cancer, mid-2019
Financial Guidance:

Going forward, the company’s revenue guidance will be on product sales only, and will exclude estimates for license and collaborative fees. More importantly, we will continue to provide regular updates on our clinical progress and results, and business development activities, which remain to be the core value drivers of our Company.

We had previously provided guidance for full year 2018 revenue to be in the lower end of the guidance range, inclusive of licensing-fee revenue. In our licensing fee revenue guidance we accounted for an upfront payment of US$14.5 million from Chongqing Jingdong Pharmaceutical. As announced in early March 2019, the agreement with Chongqing Jingdong Pharmaceutical was terminated by mutual consent, leading to our 2018 reported revenue.

Athenex is forecasting that product sales in 2019 will increase by between 25% and 30% year-over-year from $56.4 million in 2018.

Conference Call and Webcast Information:

The Company will host a conference call and live audio webcast today, Monday, March 11, 2018 at 8:30 a.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13687139.

The live conference call and replay can also be accessed via audio webcast at View Source and also on the Investor Relations section of the Company’s website, located at www.athenex.com.

A replay of the call will be accessible two hours after its completion through March 18, 2019 by dialing 844-512-2921 (domestic) or 412-317-6671 (international) and entering passcode 13687139.

On March 11, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin therapeutics* to treat serious diseases, reported that it will present at the Cowen and Company 39th Annual Health Care Conference on Tuesday, March 12, 2019 at 12:00 – 12:30 PM Eastern Time (5:00 PM CET) (Press release, Molecular Partners, MAR 11, 2019, View Source [SID1234534193]). The presentation, followed by a Q&A session, will be hosted by Dr. Patrick Amstutz, CEO of Molecular Partners.

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Next to highlighting the progress of the clinical DARPin compounds, the presentation will outline the evolution of the company’s therapeutic design space in oncology research, including the recent strategic partnership with Amgen on MP0310 (FAP x 4-1BB). The presentation will also outline the initiation of a research project to explore DARPin molecules targeting peptide MHC complexes supported by Gilead. The ability to target peptide MHC complexes with DARPin molecules has the potential to open the target space significantly, as these targets have been notoriously difficult to be addressed by any antibody-based approaches.

On March 11, 2019 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported financial results for the fourth quarter and full-year ended December 31, 2018 and provided a business update (Press release, Neon Therapeutics, MAR 11, 2019, View Source [SID1234534192]).

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"2018 was a transformative year for Neon, highlighted by significant advances in applying our insights into neoantigen biology not only to our vaccine product candidates but also to our emerging cellular therapies. Our initial public offering in June provided us with capital to advance these important programs, which have the potential to truly change the paradigm for immunotherapy by enabling more targeted treatment," said Hugh O’Dowd, Neon’s Chief Executive Officer. "As we move into 2019, we are excited about the opportunities ahead to share data from our ongoing clinical trials of our personal neoantigen vaccine NEO-PV-01. We are also making progress to advance our personal T cell therapy program, NEO-PTC-01, into the clinic. We have adjusted timelines to enable the release of more mature data from our NT-002 study and to complete the scale-up process for our NEO-PTC-01 program."

"With regard to NEO-PV-01, we have been closely tracking multiple metrics of patients’ immune response following dosing with the vaccine, and we are looking forward to presenting a correlative analysis from our NT-001 trial with data from more than a dozen patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Later this year, we will present the more mature 52-week data set, which will include additional patients followed for a full year, a time frame that allows us to further evaluate not only their immune responses but also clinical outcomes, including progression free-survival," said Richard Gaynor, M.D., Neon’s President of Research and Development.

"We have also made important developments in our NEO-PTC-01 program, including the evaluation of additional patient sample materials, which builds upon data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 33rd Annual Meeting last year. The additional evaluation of both melanoma and non-small cell lung cancer patient materials confirm that NEO-STIM, our proprietary ex vivo co-culture process using peripheral blood mononuclear cells, can reliably and reproducibly generate multiple enriched neoantigen-specific T cell populations. These findings, now replicated across multiple patient samples, support the feasibility of advancing this program into the clinic.

"Finally, we have meaningfully advanced the science behind our precision medicine approaches, which target mutations shared across patient populations known as shared neoantigens. We are leveraging our NEO-STIM induction protocol to rapidly generate T cells specific to these targets where multiple T cell receptors, or TCRs, can be sequenced and characterized. Importantly, since we can derive these TCRs from the natural repertoire of healthy donors, our TCRs show cytotoxic functionality and strong specificity for mutant targets without engineering or modification. Due to our focused efforts in this area, we now have libraries of these high-quality TCRs," concluded Dr. Gaynor.

Fourth Quarter Business Highlights

In April 2019, Neon will present data relating to both its personal neoantigen vaccine, NEO-PV-01, and its personal neoantigen T cell therapy, NEO-PTC-01, at the AACR (Free AACR Whitepaper) Annual Meeting taking place in Atlanta, GA. Data from the NEO-PV-01 program will include a correlative analysis from the melanoma cohort in NT-001, a clinical trial exploring the feasibility, safety, efficacy and immunogenicity of NEO-PV-01 dosed in combination with nivolumab in patients with advanced or metastatic melanoma, non-small cell lung cancer and bladder cancer. In addition, data from the NEO-PTC-01 program will include a detailed analysis of immune responses induced against patient-specific neoantigens using its ex vivo induction protocol, NEO-STIM.

In December 2018, Neon announced that patient dosing had commenced in NT-003, a Phase 1b combination trial of NEO-PV-01 in metastatic melanoma. This Phase 1b trial is evaluating NEO-PV-01 and nivolumab in combination with other agents, including Apexigen’s APX005M, an investigational CD40 agonist, or in combination with ipilimumab, to enhance vaccine-induced neoantigen immune responses.

In November 2018, the Company presented results related to its personal T cell product, NEO-PTC-01, at SITC (Free SITC Whitepaper). Data from two melanoma patients were presented that showed that NEO-STIM can prime, activate and expand neoantigen-specific CD8+ and CD4+ T cell responses from peripheral blood mononuclear cells. Responses were shown to be mutant-specific, polyfunctional and capable of killing antigen expressing tumor targets. Since this presentation, Neon has obtained data from additional samples from cancer patients.

In November 2018, Neon was named one of the top places to work in Massachusetts by The Boston Globe, an honor awarded based on employee feedback. The Top Places to Work awards recognize the most admired workplaces in the state as voted on by the employees of those companies. The annual survey, now in its eleventh year, measures employee opinions about their company’s direction, management, culture, pay and benefits and engagement with employees, among other factors.
Pipeline Overview and Upcoming Milestones

NEO-PV-01

NT-001: Phase 1b Clinical Trial of NEO-PV-01 in the Metastatic Setting
– Neon will present updated correlative data from its NT-001 trial at the AACR (Free AACR Whitepaper) Annual Meeting.
– Full 52-week data, including clinical outcomes, will be presented later in the first half of 2019.

NT-002: Phase 1b Clinical Trial of NEO-PV-01 in Metastatic Non-Small Cell Lung Cancer
– Neon now expects to report immune and clinical data over the course of 2020.

NT-003: Phase 1b Clinical Trial of NEO-PV-01 in Metastatic Melanoma Combinations
– Neon expects to report immune monitoring data in the first half of 2020.

NT-004: Phase 1b Clinical Trial of NEO-PV-01 in Earlier Disease Setting
– Planning ongoing.
NEO-PTC-01

Neon will present a detailed analysis of immune responses induced against patient-specific neoantigens using its ex vivo induction protocol, NEO-STIM, at the AACR (Free AACR Whitepaper) Annual Meeting.

Building on our success to date in generating both memory and de novo immune responses, Neon is in the process of completing large scale process development, which supports its plan to file a Clinical Trial Application in Europe in the second half of 2019 for the first clinical trial of this cell therapy.

This work is being performed in collaboration with the Netherlands Cancer Institute (NKI), an academic research and treatment center with leading expertise in T cell biology and treatments.
NEO-SV-01

Phase 1 Clinical Trial in Subset of ER+ Breast Cancer: Following the completion of target validation and preclinical product development work, Neon expects to submit an Investigational New Drug application to the U.S. Food and Drug Administration in the first half of 2019.
Fourth Quarter and Full Year 2018 Financial Results:

Cash Position: As of December 31, 2018, cash, cash equivalents and marketable securities were $103.3 million, as compared to cash, cash equivalents and marketable securities of $79.7 million as of December 31, 2017.

R&D Expenses: R&D expenses were $18.0 million for the fourth quarter of 2018 and $60.4 million for the year ended December 31, 2018, as compared to $10.9 million for the fourth quarter of 2017 and $37.2 million for the year ended December 31, 2017. The increase for both fourth quarter and full year 2018 was primarily driven by increased costs related to the advancement of NEO-PV-01, as well as higher personnel costs.

G&A Expenses: G&A expenses were $5.8 million for the fourth quarter of 2018 and $18.3 million for the year ended December 31, 2018, as compared to $3.7 million for the fourth quarter of 2017 and $10.9 million for the year ended December 31, 2017. The increase for both fourth quarter and full year 2018 was primarily driven by increased costs of being a public company, including professional fees and personnel costs, as well as other general and administrative costs to support Neon’s overall growth.

Net Loss Attributable to Common Stockholders: Net loss was $23.1 million for the fourth quarter of 2018 and $83.3 million for the year ended December 31, 2018, or a net loss per basic and diluted share of $(0.84) and $(5.54), respectively, as compared to a net loss of $17.4 million for the fourth quarter of 2017 and $57.9 million for the year ended December 31, 2017, or a net loss per basic and diluted share of $(8.93) and $(34.32), respectively.
Financial Guidance

Based on its current operating plan, Neon expects that its existing cash, cash equivalents and marketable securities will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into at least the second quarter of 2020.

About Neon Therapeutics

Neon Therapeutics is a clinical-stage immuno-oncology company and a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both vaccine and T cell therapies, including NEO-PV-01, a clinical-stage neoantigen vaccine for the treatment of metastatic melanoma, non-small cell lung cancer, and bladder cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment of solid tumors; and NEO-SV-01, a neoantigen vaccine for the treatment of a subset of estrogen-receptor-positive breast cancer.

On March 11, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported US Food and Drug Administration approval of the VENTANA PD-L1 (SP142) Assay2 as the first companion diagnostic to aid in identifying triple-negative breast cancer (TNBC) patients eligible for treatment with the Roche cancer immunotherapy Tecentriq(atezolizumab)3 plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) (Press release, Hoffmann-La Roche, MAR 11, 2019, View Source [SID1234534191]). Assessment of PD-L1 biomarker status on tumor-infiltrating immune cells with the assay is essential for identifying those patients most likely to benefit from the treatment.

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A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth – estrogen receptor, progesterone receptor and HER2/neu – are not expressed on the tumor.

"Triple-negative breast cancer is an aggressive disease that, until now, has had limited treatment options," said Michael Heuer, CEO of Roche Diagnostics. "This assay plays a pivotal role in helping physicians identify patients that can benefit from Tecentriq therapy, providing better patient care. At Roche, we build on our capacity to research both targeted medicines and companion diagnostics under one roof, so we can provide the right treatment to the right patient at the right time."

The VENTANA PD-L1 (SP142) Assay was developed to enhance visual contrast of tumor-infiltrating immune cell staining. In triple-negative breast cancer, PD-L1 is primarily expressed on tumor-infiltrating immune cells rather than on tumor cells themselves.

Launched in 2016, the VENTANA PD-L1 (SP142) Assay is the primary diagnostic assay within the Tecentriq clinical development program and was used to enroll and stratify patients in Tecentriq clinical trials. The assay was the first to evaluate patient PD-L1 biomarker status using immune cell staining and scoring within the tumor microenvironment.4

About the VENTANA PD-L1 (SP142) Assay
The VENTANA PD-L1 (SP142) Assay is available on the fully automated BenchMark ULTRA instrument5 and uses the OptiView DAB IHC Detection Kit with OptiView Amplification Kit. The VENTANA PD-L1 (SP142) Assay performs specific staining of tumor cells and immune cells. The assay was previously approved by the FDA and CE marked for use as a companion diagnostic in urothelial carcinoma (UC)3 and as a predictive assay in second-line non-small cell lung cancer (NSCLC) with Tecentriq. See the Tecentriq product label for more information on PD-L1 expression levels in therapeutic guidance for various cancer indications.

About the IMpassion130 study
The IMpassion130 study is a phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer (mBC). For details of the study go to www.roche.com.

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.

Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations and for the treatment of PD-L1 positive, metastatic triple-negative breast cancer.

On March 11, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumours express PD-L1, as determined by an FDA-approved test (Press release, Hoffmann-La Roche, MAR 11, 2019, View Source [SID1234534190]). This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Programme allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.

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"The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease."

This accelerated approval is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone (median PFS=7.4 vs. 4.8 months; HR=0.60, 95% CI: 0.48-0.77, p<0.0001) in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. Overall survival (OS) results were immature with 43% of events in all randomised patients (intent-to-treat; ITT), and further data will be shared with the FDA and presented at an upcoming medical meeting.Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The most common Grade 3-4 side effects (≥2%) with Tecentriq plus nab-paclitaxel were low white blood cells, tingling or numbness in the hands and feet, neutrophil count decreased, feeling tired, low red blood cells, low blood potassium level, pneumonia and increased blood level of a liver enzyme (AST). The most common side effects (≥20 %) were hair loss, feeling tired, tingling or numbness in the hands and feet, nausea, diarrhoea, low red blood cells, constipation, cough, headache, low white blood cells, decreased appetite and vomiting.

About the IMpassion130 study
The IMpassion130 study is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 people who were randomised equally (1:1). The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) in the ITT population and in the PD-L1-positive population and OS in the ITT population. OS results were immature in the ITT population. Secondary endpoints include objective response rate and duration of response.

About Triple-Negative breast cancer
Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.1 TNBC represents 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.2;3;4 It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.5 Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.3

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Our targeted medicines Herceptin, Perjeta and Kadcyla are continuing to transform the treatment of early and advanced HER2-postive breast cancer and, through our Tecentriq and ipatasertib clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.

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.

Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.

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