Bayer Oncology Leaders Fueling Ambitious 2030 “Top 10” Target
07 Jun 2022
Small molecular drugASCOPriority ReviewAcquisition
From Left: Nelson Ambrogio and Tara Frenkl/Courtesy of Bayer.
Bayer is building an oncology powerhouse. The Germany-based biopharma leader is on a mission to become one of the top 10 oncology companies by 2030, and an ambitious mission requires an equally driven leadership team. To that end, Bayer snagged ex-GSK global oncology head Christine Roth to lead its Oncology Strategic Business Unit, then dipped into GSK waters again to bring Tara Frenkl on board as head of oncology development.
BioSpace caught up with Frenkl and colleague Nelson Ambrogio, Bayer’s general manager of U.S. oncology, ahead of the American Society of Clinical Oncology (ASCO)’s annual meeting. At ASCO, Bayer is presenting several abstracts highlighting new data from potential prostate cancer blockbuster Nubeqa (darolutamide), safety and survival outcomes for another prostate cancer drug, Xofigo (Radium-223 dichloride aka Ra-223), and long-term efficacy and safety data for patients with TRK fusion cancer treated with of Vitrakvi (larotrectinib). Investigator-initiated research involving Stivarga (regorafenib) and Nexavar (sorafenib) was presented over the weekend.
Frenkl, now in her second full month with Bayer, shared that she was attracted to the company by “the incredible opportunity, a robust pipeline and a really strong commitment to bring forward new medicines to treat cancer.” She also highlighted what she called the “unique, streamlined structure of the oncology unit.”
“I feel like it's perfectly poised to really advance new medicines and accelerate,” she said, explaining that oncology is a specialized unit in the overall Bayer structure, which allows the team to streamline processes and have more direct conversations from development right on through commercialization.
Based on the past few years at least, these streamlined processes seem to be working.
“We have launched a number of cancer treatments in the last two years. In fact, we have doubled our portfolio of treatments over the past five years,” Ambrogio said. “We continue to establish and expand our leadership in prostate cancer, which is clearly a key focus area for Bayer.”
Nubeqa, a second-generation androgen receptor inhibitor, was first approved by the U.S. Food and Drug Administration in July 2019 for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). Since then, it has continued to rack up impressive data and Bayer is aiming to make it a mainstay in several more indications, including metastatic hormone-sensitive prostate cancer (mHSPC). The FDA has granted Nubeqa Priority Review in this indication.
It would appear to have a good chance of success, too. In the Phase III ARASENS trial, the combination of Nubeqa plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel “showed a statistically significant increase in overall survival with a reduction in risk of death by 32.5% compared to ADTADT plus docetaxel,” Ambrogio said. He added that Bayer is “significantly expanding its oncology presence in the U.S. market,” and that this supplemental new drug application is one tangible example of the company’s strong desire to expand its U.S. footprint.
While Frenkl was just in her third week at Bayer at the time of the interview, she shared that among her first priorities will be to look for opportunities to expand and optimize on the company’s current successes.
“We'll take a deep look into the strategy, look for opportunities to expand and optimize and then also, make sure that internally, we're keeping certain things as streamlined as possible so that we can move as fast as possible to make these new medicines available,” she shared.
Prostate cancer, the most common male-specific cancer besides skin cancer – and the second-largest killer of men after lung cancer – is an area Frankl is particularly keen on.
“I’m really excited about the potential of Nubeqa,” she said. “It’s become a foundational drug for the appropriate prostate cancer patients, but it's really building on the strong heritage and expertise that Bayer has in prostate cancer and we continue to make significant investments in this area.”
Frankl spoke a lot about making a difference for patients and their families. In this light, she referenced the ARAMIS trial, a randomised, double-blind, placebo-controlled Phase III efficacy and safety study of Nubeqa in combination with androgen deprivation therapy in men with high-risk non-metastatic castration-resistant prostate cancer.
“It showed a significant improvement in the primary endpoint of metastasis-free survival, so essentially it showed that men live two times longer without the prostate cancer spreading to other parts of their body compared to placebo, which says a lot for levels of anxiety that patients can have with their cancer.” She shared that she has witnessed this anxiety as a practitioner.
As for the rest of the pipeline, Frankl highlighted compounds in various stages of development for breast cancer, bladder cancer, colorectal cancer and non-small cell lung cancer.
“I think we have a solid internal pipeline that's coming through and we have our near term products, but we're looking externally as well for additional opportunities to help fill the pipeline. We're very open to collaborating with others who are doing great research as well,” she said, referencing Bayer’s August 2021 acquisition of Vividion Therapeutics.
San Diego-based Vividion identifies previously unknown binding pockets in undruggable targets with its cutting-edge chemoproteomics platform. Bayer paid $1.5 billion upfront for the technology.
“They have very advanced technology…and it has potential to identify drug targets that unlock so far undruggable targets,” Frankl said, adding that she thinks the word “undruggable” will soon become antiquated. “With this acquisition, we really have this unique drug discovery engine that we can combine with our small molecule expertise and also help fill the pipeline.”
As this deal clearly shows, Bayer is making a significant investment in oncology in service of the earlier outlined 2030 goal.
“We are investing almost 50% of our global R&D budget in the oncology field and are prioritizing innovative approaches and addressing areas of high unmet need,” Ambrogio shared.
He added that precision oncology is another key priority for Bayer, pointing to Vitrakvi, which was approved in November 2018 by the FDA for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.
“In the age of precision medicine, we now understand that cancer is defined by genomic makeup, which has a profound impact on what doctors can learn about the patient's diagnosis and more importantly, how it should be treated,” Ambrogio said.
He outlined other priority R&D efforts which include utilizing efficient molecular oncology to help people living with cancer and enable others to benefit from molecular tests and targeted treatments through biomarker testing, targeted radionuclide therapy and immune-oncology.
Ambrogio concluded, “Our presentations at ASCO will certainly continue to reinforce our position as an innovator in oncology, our ongoing dedication to improving the lives of a wide array of people with cancer and our aspiration to become one of the top 10 companies by 2030.”
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