Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. Here, we take a look at the top four disease areas and some of the key developments in 2022.
1. Breast cancer
In April, Biotech ISA Pharmaceuticals launched a clinical trial using its Amplivant adjuvant technology to test Scancell’s Modi-1 vaccine in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer.
AstraZeneca and Meck’s Lynparza (olaparib) was approved in both the EU and the US in 2022 for patients with early-stage breast cancer. The decision was based on the results of the Phase III OlympiA trial, which showed that adding olaparib to standard treatment for patients with high-risk, early-stage breast cancer and inherited faults in their BRCA genes can cut their risk of dying by 32%.
In June, Eli Lilly’s Verzenios (abemaciclib) received a positive opinion from the UK’s National Institute of Health and Care Excellence (NICE) for use in combination with endocrine therapy for patients with hormone receptor-positive, HER2-negative, node-positive early breast cancer.
Data from the company’s Phase III MoncarchE trial, which involved 5,637 patients, showed that 91% of patients in the first cohort displayed a 32% decreased risk of breast cancer recurrence compared to standard endocrine therapy (ET).
Then in December, in a Phase III trial, AstraZeneca’s capivasertib combined with hormone therapy doubled the time it took for cancer to progress in people with advanced forms of the most common type of breast cancer.
Professor Kristian Helin, Chief Executive at The Institute of Cancer Research, London, commented on the findings: “This is a landmark moment for the treatment of advanced forms of the most common type of breast cancer. Capivasertib could offer a completely new treatment option for these patients.
2. Covid-19
Despite established vaccine programmes, 2022 was still a busy year for developments in both vaccines and treatments for Covid-19 as the industry tackled the new Omicron variant.
At the start of the year, a study sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID) proved that an additional dose of a Covid-19 vaccine is safe in adults who had previously received a full regimen of an approved vaccine.
AstraZeneca’s Evusheld became the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in the UK. Results from the PROVENT Phase III trial showed a significant reduction in the risk of developing symptomatic Covid-19 and that the protection continued for at least six months.
In April, the World Health Organisation (WHO) recommended Pfizer’s oral antiviral drug for patients with non-severe Covid-19 who are at highest risk of hospitalisation, based on data from two trials involving 3,100 patients.
GSK and Sanofi were the first companies to report positive efficacy data from a vaccine targeting the Omicron variant. The candidate demonstrated 64.7% efficacy in symptomatic Covid-19 adults and 72% efficacy in Omicron cases in the Phase III trial VAT08 in over 13,000 patients.
In July, Novavax submitted a request to Swissmedic to expand the use of its vaccine Nuvaxovid into adolescents and as a booster dose for adults. This was approved based on the PREVENT-19 Phase III trial, which included 2,247 adolescents and demonstrated 80% clinical efficacy, and a Phase II trial into the vaccine’s use as a booster.
An updated version of Moderna’s Covid-19 booster vaccine, ‘Spikevax’, was approved for use in UK and the US, as it was proved to target the original coronavirus strain as well as the Omicron variant.
In the US, a 2021/22 multi-site clinical trial into the effectiveness of metformin, ivermectin and fluvoxamine in non-hospitalised adults showed that metformin is effective in preventing severe illness.
October saw completion of enrolment into a Phase III trial for a new class of booster vaccine; Vaxxinity’s UB-612, a heterologous booster vaccine to mRNA, adeno-vectored, and inactivated primary series vaccinations.
Then in November, the results of a large randomised, double-blind study at UMC Utrecht revealed that prednisolone does not improve sense of smell after Covid-19.
Late 2022/early 2023, a monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, entered clinical trials less than 12 months after discovery, as AstraZeneca launched the SUPERNOVA Phase I/III trial.
3. Prostate cancer
A new metastatic prostate cancer drug was approved by the FDA in March, followed by the European Commission in December. Novartis’ Lutetium-177 PSMA-617 is limited to cases carrying the surface molecule PSMA (prostate specific membrane antigen) and in patients who had previously received chemotherapy and who do not respond to hormone withdrawal.
Clinical trials continue to determine whether Lutetium-177 PSMA-617 provides a survival benefit to patients who have not previously received chemotherapy.
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone was approved in the EU for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy is not clinically indicated.
The approval was based on results from the PROpel Phase III trial, however, the drug was rejected by UK regulator NICE because it requires expensive genetic testing.
In November, England became the first country in Europe to roll out darolutamide (Nubeqa) to patients whose prostate cancer has spread to other parts of the body.
Chiara De Biase, Director of Support and Influencing at Prostate Cancer UK, said: “It’s fantastic that thousands of men are being given early access to darolutamide alongside traditional hormone therapy and chemotherapy, which could massively improve their survival. This is great news for men, and we hope that this temporary approval leads to the treatment being rolled out permanently across the UK.”
4. Solid tumours
At the start of the year, MiNA Therapeutics dosed the first patient in its global Phase II clinical trial (OUTREACH-2) of MTL-CEBPA in combination with sorafenib in advanced hepatocellular carcinoma (HCC or liver cancer).
There was good news from 4D Pharma’s Phase I/II study of a combination of MRx0518 and Keytruda in treating renal cell carcinoma (RCC) that has progressed on a prior immune checkpoint inhibitor (ICI).
Australian biotech Noxopharm was granted Orphan Drug Designation from the FDA for Veyonda and announced continued Phase I investigations in combination with doxorubicin for first-line treatment of soft tissue sarcoma.
In June, the European Commission (EC) approved Kite’s CAR-T therapy Yescarta for patients with follicular lymphoma (FL), following an overall response rate of 91% and a complete response rate of 77% in the single-arm Phase II ZUME-5 study.
A groundbreaking ‘immunoablative’ neoadjuvant immunotherapy clinical trial at Memorial Sloan Kettering Cancer Center (MSK) reported a 100% complete response rate in MMRd locally advanced rectal cancer. The data showed a complete response in all 14 patients who received dostarlimab as a first-line treatment.
Excellent interim results from the ongoing RINGSIDE Pivotal Phase II and III clinical trial into Ayala Pharmaceuticals’ gamma-secretase inhibitor AL102 in rare desmoid tumours were announced in September. The data showed that AL102 demonstrated an early and meaningful effect on tumours within 16-weeks and was well tolerated.
Following this, the FDA granted Orphan Drug Designation to Avacta Group’s chemotherapy drug, AVA6000, for the treatment of soft tissue sarcoma. An ongoing Phase I clinical trial will assess the safety and pharmacokinetics of AVA6000, which has potential in a range of cancer types.
In November, Triumvira Immunologics revealed positive data from its ongoing TACTIC‑2 Phase I/II trial of cell therapy TAC01-HER2 in patients with human epidermal growth factor receptor 2 (HER2) positive solid tumours. Clinical activity was observed in the two higher dosing cohorts, with a 67% disease control rate in cohort 3.
In the same month, DynamiCure launched its Phase I clinical trial evaluating anti-CD93 monoclonal antibody candidate, DCBY02, in adults with a wide range of advanced cancers.
While changes to how clinical trials are conducted and trial data is managed are likely in 2023 and going forward, and we can expect less attention on Covid-19, it is a safe bet that oncology will remain an area of focus for many companies.
