ESMO review: advances in immunotherapy, EMA dialogue and patient power

QuintilesIMS’s Cristina Oliva talks to pharmaphorum about her personal highlights from this year’s European Society for Medical Oncology (ESMO) congress in Copenhagen.

Cancer is without question currently the most important therapeutic area for pharma, producing some of the sector’s most exciting scientific breakthroughs and advances in treatment.

Over the last few years, the annual US-based American Society of Clinical Oncology (ASCO) congress has been the place where many of these breakthroughs have been unveiled, but this year its European counterpart ESMO has provided the most exciting news.

A huge total of 1,640 studies were presented at ESMO 2016, which was held this year in Copenhagen, including 47 late breaking trials and over 1500 posters.

Picking out the highlights from this flood of data can be difficult, but there was a general consensus that new trial data from immunotherapy treatments were among the most notable advances.

Dr. Cristina Oliva is senior medical director, Oncology, Therapeutic Science and Strategy Unit of (the newly-merged) QuintilesIMS. She was among the more than 20,500 people who attended the meeting, and picks out for us a few of her own highlights.

She says these fall into a handful of categories: advances in immunotherapy; dialogue with regulators and novel trial methodologies to accelerate trials; the continuing rise of patient power and the first biosimilar cancer therapeutics.

Immunotherapy advances

“This year’s ESMO was one of the most impressive I’ve ever attended, because there were several clinical trials which are potentially game-changers - there was a tangible excitement about these studies around the congress,” says Dr. Oliva.

Dr. Oliva says immunotherapy studies were presented across a range of different tumour types, in different lines of therapy, as monotherapy and in combinations.

In non-small cell lung cancer (NSCLC) in particular, there was some impressive results in first line treatment– anti- PD-1 immunotherapy pembrolizumab compared to chemotherapy showed significantly prolonged progression-free survival (PFS) and overall survival (OS) and fewer adverse events in patients with PD-L1 tumour expression, a very hard to treat tumour type.

Pembrolizumab has demonstrated its efficacy not only as a first line-monotherapy, but also in combination with chemotherapy. These groundbreaking data will certainly affect the treatment options available to patients with NSCLC.

There were also important advances in recurrent ovarian cancer, HER2 negative advanced breast cancer, stage III melanoma and head and neck cancers.

A revolution in early phase trials, greater dialogue with regulators

Dr. Oliva says many of the data presentations and educational sessions at ESMO reflected radically new approaches to early stage trials.

“Early stage oncology clinical trials are being transformed – we are now seeing phase 1 studies enrolling up to 1,000 patients, a completely new phenomenon. The aim is to accelerate drug access for patients, and to reach proof of concept in different indications as rapidly as possible.”

“That is the exciting part, and I think we can call this a revolution in clinical research,” says Dr. Oliva, and says this has also brought about a sea change in the approach of regulators, most notably the US FDA, but also Europe’s EMA.

Clearly, regulators are trying to innovate as well, and novel methodologies such as adaptive pathways, basket trials and single arm studies are all being tried out.

However, Dr. Oliva cautioned: “We still need to keep in mind that efficacy needs to be confirmed and that for most of the cancer indications, randomised clinical trials remain the standard.”

She also commended in particular on an educational session chaired by Dr Francesco Pignatti, the EMA head of oncology.

His ESMO presentation helped to spread the word about the EMA’s accelerated platforms, which aim to speed up access to new drugs, especially in orphan diseases.

“I think that’s proof again of how clinical research is changing – all the different stakeholders are getting involved – regulators, clinical researchers, sponsors and also patients,” she says.

In his presentation, Pignatti touched on the inevitable comparisons between the FDA and its Breakthrough Therapy Designation and similar EMA initiatives such as PRIME (PRIority Medicines)

“He recognised that the FDA is quicker in their review and approval process,” says Dr. Oliva. “At the same time, the EMA and FDA now work together very closely. They have monthly teleconferences where they review all the applications, and try to align their policies on challenges which emerge in regulatory reviews. That’s a very important connection between the two agencies, and that will shape the direction of regulatory conversations on both sides of the Atlantic.”

Patients as clinical trial stakeholders

Another notable success of this year’s ESMO was how it managed to fully integrate patient viewpoints into its programme, something with which other congresses have struggled.

“There were an unprecedented number of patient-related sessions included in the official programme of ESMO. I think that shows that the patient voice is being heard louder and louder.  Patient advocates are interested in all aspects of clinical trials, such as safety, but most of all the potential efficacy of new agents.”

Patient advocates are becoming more and more knowledgeable about new clinical trial methodologies, and are even considering how independently-organised clinical trials can be set up.

Dr. Oliva says the greatest participation can often be found in rarer cancers, such as mesothelioma, (reflecting its need for multi-disciplinary management and treatment options) and sarcoma, where Dr. Oliva says patients have expressed strong views.

“We’ve had quality of life questionnaires for years now, but we are moving into a different stage where patients are becoming full stakeholders in clinical trials and trial design. They want to be involved, so we need to respond to this and adapt our processes to include them.”

The first oncology biosimilars

Many pharma companies and contract research organisations are now working on a biosimilars, which are already bringing new competition to a range of disease areas – and helping to broaden access to these medicines.

There haven’t been any biosimilar versions of cancer treatments until now, but that is about to change, and two trials of a biosimilar trastuzumab (Roche’s Herceptin) were presented in Copenhagen.

“This was a milestone for cancer treatment. Biosimilars can broaden access to these highly effective drugs around the world, often in regions and in patient groups who don’t currently have access.”

Dr. Oliva concludes: “If these biosimilars can confirm their efficacy versus the originator drug, they can bring benefits to many more patients than before."

Watch the 5 Challenges in Today’s Immuno-Oncology Trials webinar here

For further content relating to the challenges of immuno-oncology trials please click here.