|20th June 2019
(Image) From left to right: Former Vice President Joe Biden, Laura Holmes-Haddad, Dr Mark Moasser and Jill Biden
When I first met Laura seven years ago, she had been diagnosed with inflammatory breast cancer and the standard chemotherapy treatment had failed. The community oncologist had told her there was nothing else they could do for her. She was at a stage of cancer where the initial treatments should have worked but they didn’t. Her family were worried they were going to lose her, so we rushed through the referral.
It is common for community hospitals to refer to university hospitals like ours. However, sometimes there are economic barriers. Often, hospitals don’t like losing their patients because they want to keep bringing in income. It’s usually the patients who are the driving force saying, ‘I want something more, I want something better’.
At the time, genetic testing was emerging as a new way to understand cancer. We conducted a standard gene test and discovered that Laura was a BRCA2 mutation carrier.
I was aware of ongoing research in the biology of cancers arising in BRCA2 mutation carriers. The research was showing that these cancers are particularly susceptible to carboplatin, an ancient chemotherapy often used as standard practice. The tumour is also vulnerable to poly (ADP-ribose) polymerase (PARP) inhibitors, which work by preventing the PARP protein from repairing cancer cells and as a result, cause the cells to die.
I felt that using carboplatin on its own would not be strong enough to treat Laura’s cancer. I wanted her to access the best treatment possible. I also knew that carboplatin was especially effective when used with another chemotherapy called gemcitabine, as the two drugs are known to be synergistic.
PARP inhibitors were still in the early phases of drug development and not yet available on the market. I found a few clinical trials in the California area. Laura was eligible for one, which tested the PARP inhibitor and carboplatin, but there was another one in Los Angeles that tested the PARP inhibitor with the gemcitabine-carboplatin combination.
The trial wasn’t designed for patients like Laura with the BRCA2 mutation, but the research suggested it would be a potent treatment for her type of cancer. The trouble was the researchers had completed accrual on it. They had closed the trial and wouldn’t take her on. We put some pressure on and they finally opened up the trial to allow in one more patient.
Laura was a little nervous about going on a clinical trial, but when I told her about the low success rates for standard treatment and explained the hypothesis and clinical data behind the cocktail of drugs, she quickly got on board.
She made the decision to participate in the Los Angeles trial and for several months she had to fly backwards and forwards. Cancer patients require a lot of support, regardless of whether they are trying a novel therapy or undergoing chemotherapy. We were in constant contact – she asked lots of questions about blood counts, side effects and what happens next.
Laura is extremely family-oriented; her husband and her sister were all involved. She had a great support group, which is very important for anyone suffering from cancer – it’s not something you can go through alone.
She responded wonderfully to the treatment, and the trial was followed by surgery and radiation. But it wasn’t time to celebrate yet because cancer can quickly come back. We stopped the chemotherapy, but we decided to carry on with the PARP inhibitor – it was more tolerable, and it could be taken orally once a day.
Then we hit another hurdle; there was no clinical trial for that prolonged treatment. I had to cook something up. I submitted an application to the Food and Drug Administration (FDA) for a single patient use.
First, I asked the company to supply pills for Laura, then I got special permission from the FDA for a single patient clinical trial and they approved it. Laura took the pill for another year as a preventative medicine.
When she got the all clear it was excellent – it was a very good feeling for her and a very good feeling for us. It’s the time that has gone by with Laura remaining free of disease that is cause for celebration.
|18th November 2019
In this special pack, we provide a comprehensive outlook of launch excellence. We cover topics ranging from gathering effective insights, to understanding the current landscape, and the importance of pre-launch strategy for improving relationships between the customer and the brand.
|1st November 2019
In 2017 the approval of the first CAR-T treatment took the world by storm, transforming the way cancer is treated, but two years later more than 500 CAR-Ts are in development. So how can pharma ensure its product stands out from the crowd?