Genentech official sheds light on the current cancer drug pipeline.
Genentech official sheds light on the current cancer drug pipeline.
The researchers at Genentech have a long history of firsts within the world of oncology, and that trend continues currently with recent developments from a drug called atezolizumab. The drug, a new alternative to chemotherapy for those with bladder cancer and non-small cell lung cancer, reduced the risk of death by half for patients compared with chemotherapy.
In a recent interview with Specialty Pharmacy Times, Holli Kolkey, a Genentech representative, shared the most recent groundbreaking developments in the company’s pipeline. Her insights provide a new perspective for both patients and physicians alike as she describes the work that has been completed by Genentech in finding optimal treatments in the fight against cancer.
SPT: Please discuss the ongoing developments and research in the Genentech immunotherapy program?
Kolkey: The program includes more than 20 different medicines that are in development, 7 of which are in human clinical trials. Atezolizumab (or Atezo, we call it for short), is the most advanced cancer immunotherapy in the program, and that has 11 ongoing phase 3 studies.
SPT: How do you see immunotherapy evolving in the future?
Kolkey: One of the components of the Genentech immunotherapy program is that we have a really deep understanding of the disease biology and of the interaction of the immune system with cancer. The way that we have approached the cancer immunotherapy program is to identify which steps in that cancer immunity cycle play a significant role and then develop medicines that target or interact with the immune system and cancer at various stages of the cycle.
The medicines that we have in development target various steps within that cycle and some of the combinations of medicines that we are investigating in cancer immunotherapy combine 2 steps in the cycle. So, something like atezolizumab, for example, is a medicine that removes the breaks from the immune system. And then there are other medicines like OX40 that actually activate the immune system. So theoretically, we’re evaluating combining them together so that you’re removing the breaks at one stage of that cancer immunity cycle and accelerating the immune system at another point.
SPT: What developments in this area of research do specialty pharmacists need to keep their eye on?
Kolkey: I think the area of cancer immunotherapy is really evolving rapidly and I think some of the things that we will continue to learn is going to be when in the treatment continuum to use cancer immunotherapies. So, for example, in melanoma do you immediately use a cancer immunotherapy or do you start with a targeted therapy and then upon regression move on to a cancer immunotherapy? So where within the treatment continuum are they integrated into care with other targeted medicines? How long are they used for and how are they combined? It’s these types of things that will be of most interest to specialty pharmacists.
SPT: What implications does atezolizumab have for patients with non-small cell lung cancer?
Kolkey: We’re in advanced stages, and in phase 3 in evaluating lung cancer, bladder cancer, triple negative breast cancer, and kidney cancer. I think that potentially the implications are the same and ultimately results from clinical trials will need to read out to validate the medicine. But the hope is that we can identify people who are most likely to respond with the use of a biomarker, and that these people who receive the medicine have better outcomes on a cancer immunotherapy like Atezo compared to what currently is available. Ultimately, it will be those ongoing studies that will determine if that is in fact the case, but that is the hope. I think at Genentech we have a long heritage of firsts. Developing the first personalized medicine with Herceptin and having the very first medicine ever approved with a companion test which was BRAF. Our goal is really to make significant strides forward with the medicines that we’re developing.
SPT: With the growing cost of specialty drugs and the issues of adherence declining as out of pocket costs grow, is Genentech taking any steps to ensure patients are able to access new immunotherapy treatments?
Kolkey: We definitely recognize that our medicines can’t help a person unless they have access to it. First and foremost, they need to be able to have access to the medicine. So, Genentech has a very extensive Patient Assistance Program with about 350 employees who are dedicated to helping people with access. That can be navigating insurance, it can be support with copay assistance, we have a pretty extensive copay assistance program, and it could potentially be for people who need access to medicine for free. In 2014, we helped 180,000 people access our medicines. We have recently made some changes to our copay assistance program that expands the criteria for people to qualify for it, and so I think the example of broadening that copay program will make it even more accessible.
SPT: Please discuss the efficacy potential of atezolizumab in treating tumors.
Kolkey: So far, we have presented publically early phase 1 results in bladder cancer that were very encouraging and showed that about half of people responded to the medicine. In lung cancer, at ASCO this year we presented phase 2 results that showed that Atezo reduced the risk of death by half, and that was overall survival. The response rates in bladder cancer were 43%. Historically for chemotherapy, it’s in the single digits, so it’s a pretty significant advancement. What’s really exciting about Atezo and bladder cancer is that there have been no treatment developments in over 30 years.
Chemotherapy has been the only option for patients, so someone today getting diagnosed with bladder cancer is getting the same treatment that their father or grandfather got. So it’s particularly exciting in bladder cancer. We just recently announced that we unblinded the results from our pivotal phase 2 study and that it did improve response rates for people. We have not yet announced the actual numbers, but we will announce them at a medical meeting within the next month. In lung cancer, we did announce results for a phase 2 study called POPLAR and that was actually comparing Atezo to chemotherapy. The primary endpoint of the study, the goal, was to improve overall survival for people on Atezo compared to docetaxyl chemotherapy. The hazard ratio was 0.47, which means that we reduced the risk of death by half. The actual months of improvement in overall survival, those numbers had not been reached at the time we announced the results, but they will be presented at a medical meeting next month as well.
SPT: What types of developments in oncology can specialty pharmacists expect from Genentech in the future?
Kolkey: This is a really exciting time for Genentech. We obviously have a long heritage of developing medicines to treat people with cancer. We’re really seeing the sort of next wave of development in our pipeline come to fruition and we hope that in the next year we will have four new medicines approved to treat cancer. One is cobimetinib, that is for melanoma and it’s used in combination with zelboraf, and that is currently under review with the FDA right now with a tentative approval date in November 2015. The cobimetinib-zelboraf combination was just approved in Switzerland, so that was its first regulatory approval and we hope that it’s approved by the end of the year in the United States.
There is alectinib, which is for ALK positive non-small cell lung cancer, and we announced pivotal results of that study at ASCO this year. We will be submitting that to the FDA this year under breakthrough therapy designation. We have venetoclax, which is for a type of blood cancer called CLL with 17P deletion that also has breakthrough therapy designation and will be submitted to the FDA. We have atezolizumab, which has breakthrough therapy designation for both lung and bladder cancer, and we anticipate submitting those data to the FDA in early 2016. So in the next year, we could potentially have 4 medicines for 5 different types of cancer.