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BOULDER, Colo. & BERLIN--(BUSINESS WIRE)--Bayer and ArcherDX, Inc. today announced a global collaboration for the development and commercialization of a next-generation sequencing (NGS)-based companion diagnostic (CDx) for Vitrakvi^® (larotrectinib). The primary objective of the collaboration is to broaden patient access to comprehensive genomic testing inclusive of neurotrophic receptor tyrosine kinase 1 (NTRK1), NTRK2 and NTRK3 gene fusions and to help improve identification of appropriate treatment options for patients with TRK fusion cancer which can lead to meaningful treatment options.

Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.¹

Genomic cancer testing helps detect changes in a tumor’s DNA, called genomic profiling, that can determine how the cancer behaves and why it grows or spreads.² Almost 50 percent of patients who undergo genomic cancer testing may have actionable genomic alterations, meaning the alterations can be matched to treatments that have been approved or are in clinical trials.^3,4 Genomic cancer testing has already impacted patient cancer care in both common and rare malignancies. This has allowed for the identification of personalized treatment options.⁵ However, studies show that only a small percentage of cancer patients undergo such testing.⁵ It is therefore critical that testing becomes part of routine clinical practice to help guide treatment choice.

“In order to help more patients to benefit from Vitrakvi, broader access to high quality testing via next-generation sequencing is of key importance,” said Robert LaCaze, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. “The collaboration with ArcherDX perfectly complements Bayer’s CDx strategy and fits our ambition to provide the right treatment to the right patients with cancer.”

“Barriers currently exist that inhibit the broad adoption of genomic testing to inform treatment decisions. A kit-based CDx that is tumor agnostic and detects all NTRK gene fusions will enable high-quality genomic testing to be deployed in regional and community settings, where 85 percent of cancer patients receive care.⁶ For these patients, our technology provides RNA-based profiling for the detection of actionable fusions across known and novel NTRK fusion partners,” said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. “We are pleased to collaborate with Bayer to address their medical need and accelerate access to therapy.”

NGS-based CDx tests aim to unlock molecular information from each patient’s tumor genome to guide treatment decisions for cancer therapies. ArcherDX is developing and pursuing regulatory clearances for an in vitro diagnostic (IVD), a comprehensive NGS-based therapy selection product that utilizes Archer’s proprietary Anchored Multiplex PCR (AMP™) technology to measure clinically relevant genomic mutations for tumor profiling and CDx from both tissue and blood.

ArcherDX and Bayer are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2 and NTRK3 for Vitrakvi and plan to seek approval in different markets, including the European Union (EU), U.S. and Japan. The CDx version of this panel will allow local laboratories to provide referring physicians with potentially actionable genomic information, so that appropriate patients can be matched to specific therapeutic options based on their genomic findings.

The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration. Financial terms of the agreement were not disclosed.

About Vitrakvi^® (larotrectinib)

Vitrakvi^® (larotrectinib) is a first-in-class TRK inhibitor for TRK fusion cancer across solid tumors. Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.¹

Vitrakvi is approved in several markets, including the U.S., EU, Canada and Brazil.

TRK fusion cancer is rare overall, affecting no more than a few thousand patients across the U.S. and Europe. It affects both children and adults and occurs in varying frequencies across various solid tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body.

Important Safety Information for VITRAKVI^® (larotrectinib)

Neurotoxicity: Among the 176 patients who received VITRAKVI, neurologic adverse reactions of any grade occurred in 53% of patients, including Grade 3 and Grade 4 neurologic adverse reactions in 6% and 0.6% of patients, respectively. The majority (65%) of neurologic adverse reactions occurred within the first three months of treatment (range 1 day to 2.2 years). Grade 3 neurologic adverse reactions included delirium (2%), dysarthria (1%), dizziness (1%), gait disturbance (1%), and paresthesia (1%). Grade 4 encephalopathy (0.6%) occurred in a single patient. Neurologic adverse reactions leading to dose modification included dizziness (3%), gait disturbance (1%), delirium (1%), memory impairment (1%), and tremor (1%).¹

Advise patients and caretakers of these risks with VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dose when resumed.¹

Hepatotoxicity: Among the 176 patients who received VITRAKVI, increased transaminases of any grade occurred in 45%, including Grade 3 increased AST or ALT in 6% of patients. One patient (0.6%) experienced Grade 4 increased ALT. The median time to onset of increased AST was 2 months (range: 1 month to 2.6 years). The median time to onset of increased ALT was 2 months (range: 1 month to 1.1 years). Increased AST and ALT leading to dose modifications occurred in 4% and 6% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 2% of patients.¹

Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed.¹

Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman. Larotrectinib resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily.¹

Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the final dose of VITRAKVI.¹

Most Common Adverse Reactions (≥20%): The most common adverse reactions (≥20%) were: increased ALT (45%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%).¹

Drug Interactions: Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors (including grapefruit or grapefruit juice), strong CYP3A4 inducers (including St. John's wort), or sensitive CYP3A4 substrates. If coadministration of strong CYP3A4 inhibitors or inducers cannot be avoided, modify the VITRAKVI dose as recommended. If coadministration of sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs.¹

Lactation: Advise women not to breastfeed during treatment with VITRAKVI and for 1 week after the final dose.¹

Please see the full Prescribing Information for VITRAKVI^® (larotrectinib).

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer^® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex^®, FusionPlex^®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

© 2020 Bayer

BAYER, the Bayer Cross and VITRAKVI are registered trademarks of Bayer.

Bayer Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

ArcherDX Forward-Looking Statements

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This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding ArcherDX’s goals and strategic plans. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

*Included 121 patients with 93 patients evaluable by blinded independent review committee (BIRC) based on July 2018 data cuto­ff (17.7 months of follow-up)

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References

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1. Vitrakvi [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2019.
2. Cancer Treatment Centers of America. Advanced genomic testing. https://www.cancercenter.com/treatment-options/precision-medicine/advanced-genomic-testing. Accessed March 2020.
3. Boland GM, Piha-Paul SA, Subbiah V, et al. Clinical next generation sequencing to identify actionable aberrations in a phase I program. Oncotarget. 2015;6(24):20099-20110.
4. Massard C, Michiels S, Ferte C, et al. High-throughput genomics and clinical outcome in hard-to-treat advanced cancers: results of the MOSCATO 01 trial. Cancer Discov. 2017;7(6):586-595.
5. Malone, E.R., Oliva, M., Sabatini, P.J.B., et al. Molecular profiling for precision cancer therapies. Genome Med. 2020;12(8). https://doi.org/10.1186/s13073-019-0703-1
6. El-Deiry, W., et al. The current state of molecular testing in the treatment of patients with solid tumors, 2019. Cancer J Clin. 2019;69(4): 305-343.

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