CHICAGO, Ill. -- The American Society of Clinical Oncology (ASCO) is one of the most eye-catching events in the global biotech industry, as it provides opportunities to gauge the clinical success of pipelines on the global oncology stage.

Roche, a multinational pharmaceutical company, has been playing an important role in ASCO for more than 50 years, by highlighting data from its numerous pipelines of treatments in the field of oncology. This year, Roche plans to present new data from clinical trials of 17 approved and investigational medicines across 27 cancer types, including hard-to-treat and rare tumors, at ASCO 2019.

The Korea Biomedical Review met with two Roche executives on Friday before the company started presenting its research at the conference to discuss what the company plans on presenting at ASCO in detail as well as its plans and goals and the company's operation specifically in Asia. The two officials are Alan Sandler, Roche's global head of clinical development and senior vice president for global product development for solid tumors and oncology, and Cathi Ahearn, Roche's franchise head for GI/GU cancers, cancer immunotherapy & Tecentriq cross-indication.

KBR: What are some key data that Roche plans to present during ASCO 2019?

Alan Sandler: For this year's ASCO, the key data include IMpower150 (Tecentriq, Chemo and Avastin) data for metastatic non-squamous NSCLC, IMpassion130 (Tecentriq and Nab-Paclitaxel) for triple negative breast cancer, CLEOPATRA (Perjeta, Herceptin, and docetaxel) phase 3 end-of-study analysis for HER-2 positive breast cancer.

KBR: After ASCO 2019, what is Roche's focused area in the future pipeline globally?

Sandler: We have several clinical trials that are now ongoing, and there will be many data coming out in metastatic disease and other malignancies.

One of the essential data to be presented includes our research on melanoma. The company is looking at the role of Tecentriq in patients with wild-type no BRAF mutations and then those with BRAF mutations and plans to add Tecentriq as standard therapy in the area. The company is also planning to present the study on liver cancer that uses a combination therapy of Tecentriq and Avastin, and a combination of chemo and Tecentriq on bladder cancer.

KBR: Does Roche also plan on increasing clinical trials in ASEAN and Korea? If so, which area does the company plan on focusing?

Sandler: We are attempting to become more and more global, and we'd love to be able to continue the work in South Korea as we already have many investigators across multiple malignancies.

Asia is a vital region for the company. The continent is a growing community that has a high unmet medical, and we try to improve the impact of therapy in the area. Roche's goal is to continue increasing our footprint and presence by conducting global studies in Asia. We also plan to do studies that might have more of an impact in Asia and let the Asian clinical sites potentially lead the clinical trials.

Cathi Ahearn: As a global pharma company, we have a significant presence in the Asian market. I think one of the things we got better over time is learning how to partner effectively with health authorities across the Asian region to make sure that we can accelerate the availability of therapies to patients in Asia.

Such partnering has led us to conduct all of our trials globally. Particularly for areas where we think there is a high need in the Asian market such as liver cancer, we make sure that we have sufficient Asian patients in our global study so that we can have a robust data set, which in turn, enables speedy approval conversations with health authorities in the region.

KBR: Regarding the company's work with its big data-focused subsidiaries Flatiron and Foundation Medicine data, how will such big real-world data (RWD) platform change the future drug development scene for Roche?

Sandler: RWD will have a huge impact on our rare tumor treatment development. Until now, it was nearly impossible to do a large randomized phase 3 clinical trial as the population pool was so small. However, with the rise of RWD, patients with these types of mutations might not need a randomized clinical trial if there is a drug that works.

RWD can give you patients that may have had the disease but were not treated due to the lack of treatment at that time. The company can use such patient pool as a synthetic control and compare with current trial data.

Regulatory agencies are also becoming more comfortable with such a process, so I believe that this is the near term success of using RWD in the short-term.

In the future, we're going to see if we can include more of these patients from the RWD sets and ultimately reduce the number of a randomized phase 3 clinical studies as well as the time for drug approval process.

However, there are still hurdles that the company has to overcome. One of the challenges is that not all of the data set has the same criterion. This is because such data is collected from physicians not involved in a clinical trial so they don't necessarily keep the same records or detail. So evaluating response using RWD is still a bit of a challenge, and we're working on improving those databases.

KBR: As Tecentriq is a latecomer in the immunotherapy stage, what are its challenges and strengths compared to other immunotherapies?

Sandler: In some areas, Tecentriq is a latecomer, but we're starting to catch up in some areas such as small cell lung cancer and triple negative breast cancer where we are the first comer. I believe it is important to focus on the indications that the drug is targeting.

Regarding Tecentriq, while many companies did not research immunotherapy in combination with chemotherapy, we went with the idea and became one of the leaders in the field.

The company is also continuing to take other drugs from its immunotherapy pipeline and combine it with Tecentriq. I think this is an area where we have an advantage as our pipeline is so rich.

Ahearn: Drugs targeting PD-L1 and PD1 have become foundational across cancer immunotherapy, and I think there are a lot of similarities in how these drugs work. However, without doing a head to head study, it is impossible to say this drug is different from the other.

What we see in the market is that each company has chosen a different development path. Therefore, while the immunotherapies might look the same for some, there will also be indications that the company can provide a unique benefit based on the combinations that we pursued.

Regarding the scientific standpoint, we try to differentiate Tecentriq by better understanding the underlying biology so we can make smarter decisions about which trials we want to invest in and which settings we can have the most significant impact for patients.

KBR: In Korea, Roche has agreed to a performance-based reimbursement criterion, which allows reimbursements only to immunotherapies with meaningful drug response to give cancer patients instead of PD-L1 expression, to provide easier access to immunotherapies and minimize the government's spending. The government is planning to expand the policy so that the government will pay for drug's that show effect while pharma companies will pay for treatments that don't. What is the company's stance toward such reimbursement policy?

Ahearn: Above all, the company is very strongly committed to ensuring access to patients.
However, how we ensure such access gets very complicated very quickly as each market or country has a unique reimbursement system, and it is impossible to come up with a single policy that fits all.

To resolve this issue, the company is working closely with local authorities to evaluate what kind of reimbursement policy will be perfect for a certain country.

Roche is continually trying new ways of looking at reimbursement whether it’s performance-based like in Korea or population-based. While there are a number of different ways, Roche believes it is vital to take into consideration the unique elements of a drug.

We believe it is important to tailor the solution to the setting such as what does the individual patient need, how the drug is used, how long it will be used and how the reimbursement is handled in the given market.

However, one of the things that makes this process challenging is the lack of good data.
The markets where we had early success with tailoring the solution are markets that have closed systems, which mean that the government is already capturing much of the information about patient outcomes, making it very easy to track.

When we can't track such information easily, it's a lot harder to implement such a tailored system. We are trying to solve this issue by using the data provided by Flatiron with its captured outcomes data and having a meaningful set of data to compare it.

Regarding the efforts made by the global headquarters, we have a division called "Pricing and Market Access," which is focused on providing access to patients. They partner with local affiliates and find the dynamics of the reimbursement process in a particular country.

Afterward, the group gathers the information and comes up with new ideas and presents them to the local affiliates to see if there might be a better solution.

Our preference would be that we can do a better job of selecting patients on the front end that countries don't necessarily have to worry about this as much as they do now.

KBR: Recently, there has been a surge of biosimilars in oncology such as Herceptin. As an original oncology treatment leader, what is Roche's stance on biosimilars?

Ahearn: Our position is that biosimilars, in general, is a good thing as it creates room for innovation, but at the same time, we think patent protection is important as it fuels innovation. Being able to generate revenues from our innovation is what enables us to create innovation.

Especially if we think about the importance of combinations in the future, biosimilars can lower the entry cost for treatment and allow us to do more.

If every component of combination therapy is a premium-priced product, it becomes very difficult for patients to access the treatment.

All of that said, there is no doubt that biosimilars have an important role. However, at the same time, we also want to make sure that the biosimilars are held to the same standards as the original treatment, such as delivering the same therapeutic effect to patients.

As long as all manufacturers are held to a high standard of patient safety and outcome while delivering the same outcome, the introduction of a biosimilar can absolutely make sense after a patent protection period.