The analyst report, in two parts, highlights the potential and limitations of current CAR-T approaches for addressing the majority of tumour types. It provides analysis on current events in the CAR-T sector, as well as available technologies, challenges, solutions and predictions for the future of T-cell therapies overall.
The release of the report follows the fast pace of recent developments including the rapid US approval of the first T-cell therapy (Novartis’ Kymriah, a CAR-T), the likely US approval of a second CAR-T therapy from Kite Pharma and the acquisition of Kite Pharma by Gilead Sciences for $12 billion.
The report is aimed at a variety of stakeholders in the CAR-T field, including investors, development firms, academia, regulators, government and public sector bodies, and the wider market.
Neil Shah, Director of Research at Edison Investment Research, said: “Investors have understandably focused onto the dramatic success and rapid US approval of Kymriah but investors and developers need to take a wider and longer-term perspective and look at other cancers and T-cell technologies as well.
“This report gives an intelligible route map based on a deep understanding of the technical fundamentals. Investors and those right across the market confused by the blizzard of clinical detail and needing an understandable and independent perspective should read this report.
“Edison makes its content freely available to provide the fundamental analytical information needed by investors and the media.”
The first part of the report is a review of the challenges and potential of the different approaches in T-cell therapy including current CAR-T and other T-cell based approaches.
Part two gives an in depth balanced review of the various technologies looking at their potential but also their risks and uncertainties. The report was written by two leading healthcare analysts Dr John Savin and Dr Daniel Wilkinson.
Conclusions of the report:
Kymriah and other expected first wave CD19-targeting CAR-T therapies only cover 1.4% of cancers in the US and about 1% of deaths. Due to the success of CAR-T in leukaemia, 53% of T-cell clinical trials are aimed at the 10% of patients with blood cancers. Few clinical trials are seeking to extend T-cell therapy to patients who are diagnosed with major solid cancers annually; 1.2 million patients in the US alone.
The reason for the mismatch between investment and medical need is that CAR-T technology is very hard to adapt to attack solid cancers. The two most likely current options for extending T-cell therapy to treat solid tumours are NKR CAR T-cell therapy and T-cell receptor (TCR) approaches.
Both may advance rapidly if they show promising results. As solid cancers are difficult to attack, T-cell therapies might be combined with checkpoint inhibitors — as already used to treat lung and skin cancers and BiTEs.
“The challenge for T-cell therapy is to break out from the current limited niche to deliver real therapeutic change in the bigger blood cancers and especially in solid cancer therapy. That is where most of the patients are and the most medical needs arise.
“There are major questions as to whether these T-cell therapies work beyond their current limited niche and if they can be made affordable,” said Dr John Savin, lead author.
“The entire market is still learning about T-cell therapies so decisions and outcomes are uncertain, which is why Edison has dedicated resources to examine all available evidence. There are really difficult medical, commercial and logistical challenges ahead. However, the potential for major treatment advances is becoming visible and considerable opportunities are emerging,” Savin said.
Click here to read the full report
