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Covid-19 did not stop cancer treatment's development

By the Editors - 09 June 2021


In spite of the Covid-19 pandemic, developments in cancer treatment continued "to be the most impactful clinically and most numerous of all the areas in life sciences research, catching over 30 % of new medicines", an IQVIA report stated. Global spending on oncology drugs reached $164 billion in 2020, increasing at an average 14.3% over the past five years. It should exceed $260 billion by 2025, with growth slowing to 9-12% from biosimilar savings. Immuno-oncology would represent 20% of global oncology spending by 2025.

According to IQVIA, the total number of new drugs in the R&D pipeline reached almost 3,500 in 2020, up 75% since 2015, "marking the large investment and research focus in addressing the many unmet patient needs". Clinical trial starts reached a new high of 1 600 in 2020, despite the disruptions caused by the pandemic, marking a shift in focus toward rare cancers. " The early-stage pipeline includes about 1,000 promising new approaches to precision oncology, and has expanded by 43% since 2016, with a particularly rapid shift toward next-generation biotherapeutics including gene editing, CAR-T and RNA therapeutics", IQVIA said. There are at least 740 companies focused on oncology R&D, of which over 500 are solely focused in this area.

Last year, there were 17 new cancer medicines and three cancer diagnostic agents approved, with 16 that were orphan designated. There were five first-in-class medicines launched in 2020 including "new imaging agents for prostate cancer, new small molecule kinase inhibitor selumetinib for neurofibromatosis, new BCMA antibody for multiple myeloma belantamab mafodotin, tazemetostat in epitheliod sarcoma and tafasitamab in diffuse large B-cell lymphoma". In the U.S. only, there were 62 unique new cancer medicines launched in the past 5 years with many approved for more than one indication, compared to 43 in EU4+UK, 40 in Japan and 37 in China.

Still in 2020, the EMA approved 14 oncology new actives substances (NASs), twice as many compared to last year, half for rare cancers. A total of 64 oncology new active substances have launched globally in the past five years, bringing the 20-year total to 161.

The outlook for the next five years worldwide includes almost 100 NAS launches globally in oncology, up almost 50% as medicines are expected to continue to shift to more rare cancer often with fewer indications per drug. "The shift to rare cancers will be accompanied by some multi-indication medicines, often tissue-agnostic with usage predicated by pharmacogenomic testing (PGx) testing results which are expected to become much more commonplace", IQVIA said.

The 2021 American Society of Clinical Oncology (ASCO) annual meeting confirmed the trend, with lots of new releases from companies.

• In BRCA-mutated high risk early breast cancer, AstraZeneca (AZ) and Merck & Co's PARP inhibitor Lynparza demonstrated positive results according to new data from the phase 3 OlympiA trial. Lynparza (olaparib) reduced the risk of invasive breast cancer recurrence, second cancers or death by 42 % in the overall trial population, including patients who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy. At the three-year time point, 85.9% of patients remained alive and free of invasive breast cancer and second cancers versus 77.1% on placebo. The PARP inhibitor also reduced the risk of distant disease recurrence or death by 43.

AstraZeneca and Merck's Lynparza drug could become a new tool and the pharma companies are expected to submit the trial data to regulators for approval for this condition. The OlympiA trial is the first phase III study to report the effect of a PARP inhibitor in any adjuvant setting and in this context is focused on patients with germline BRCA1 or BRCA2 mutations and early-stage, high-recurrence risk breast cancer, following completion of standard multi-modality therapy, which includes a combination of chemotherapy drugs. Launched in 2014, Lynparza has shown success in later-stage breast cancer that has spread and cannot be cured, and ovarian and pancreatic cancer. About 15 % of breast cancer sufferers have cancers that do not respond to other targeted therapies.

• AstraZeneca also presented final data from its ELEVATE-RR Phase III trial of Bruton's tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib) in adults with previously treated chronic lymphocytic leukemia (CLL) at high risk for progression. In comparison with J&J and AbbVie's first generation blockbuster Imbruvica (ibrutinib), Calquence demonstrated significantly lower atrial fibrillation, fewer cardiac events, and fewer discontinuations.

Calquence met its primary endpoint, showing progression-free survival (PFS) non-inferiority versus ibrutinib with a median PFS of 38.4 months in both arms. Patients treated with Calquence were 6.6 times less likely to develop all-grade atrial fibrillation compared with those treated with ibrutinib. (9.4% versus 16.0%). Adverse events led to treatment discontinuation in 14.7% of patients on Calquence, while 21.3% discontinued treatment with ibrutinib. Calquence was approved for CLL back in November 2019, both as a monotherapy in second-line patients and as a combination treatment with Roche's Gazyva in frontline patients. But the Elevate-RR trial is the first to compare the two BTK inhibitors head-to-head in CLL, and should help AstraZeneca carve out a space in the market.

• In late stage prostate cancer, Novartis revealed new data from a phase 3 trial evaluating its targeted radioligand therapy (RLT). The phase 3 VISION study is evaluating the efficacy and safety of the targeted RLT Lu-PSMA-617 plus best standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

The data showed that men who were treated with Lu-PSMA-617 plus best standard of care achieved a 38% reduction in the risk of death and a 60% reduction in the risk of radiographic disease progression or death compared to best standard of care alone. Novartis said that it would include the results from the VISION study in an upcoming EU regulatory submission, although it did not specify the exact timeline.

• In patients with renal cell carcinoma (RCC) following nephrectomy, according to results from the Phase III KEYNOTE-564 trial, adjuvant use of Merck & Co.'s Keytruda (pembrolizumab) cut the risk of disease recurrence or death by 32%, compared with placebo. Patients with intermediate- to high-risk advanced disease are at risk for relapse, and there are currently no standard treatment options post-surgery. These results in KEYNOTE-564 mean Keytruda could become "a potential new standard of care in the adjuvant setting" to delay disease recurrence in fully-resected RCC patients.

With a median 24 months of follow-up, the estimated DFS rate was 77.3% with Keytruda, compared to 68.1% with placebo. According to the results, the estimated preliminary OS rate at 24 months was 96.6% with Keytruda and 93.5% with placebo.

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