News in brief: Checkpoint inhibitor concerns allayed in autoimmune disease; Novel TKI approved for NSCLC; New radiotherapy option for pancreatic cancer patients

Wednesday, 3 Aug 2022

Checkpoint inhibitor outcomes similar in people with autoimmune disease

Immune checkpoint inhibitors (ICIs) do not appear to be associated with worse outcomes, disease flares and immune-related adverse events (irAEs) in people with autoimmune diseases such as rheumatoid arthritis and psoriasis, a US study has found.

A review of outcomes for 1822 patients with solid tumours treated with anti-PD-1/PD-L1 therapy or combination therapy found that the 8% (n= 147) with autoimmune disease showed no difference in tumour response and overall survival compared to those without autoimmune disease.

Almost 60% of patients with autoimmune disease experienced ICI toxicity, including 14% with disease flare and 31% with irAE. However most disease flares were mild, and likewise most irAEs were mild grade 1 to 2 events.

People with active autoimmune disease had disease flare more often than those with latent disease (60% vs 22%) but conversely those  who experienced immune-associated toxic effects had higher ICI response rates (42.5% vs 8.3%), the study showed.

Writing in JAMA Oncology, clinicians from the Sloan Kettering Memorial Cancer Centre in New York said this suggests that immune associated toxic effects may be a manifestation of successful activation of T cells by ICIs.

However the caveat was that people with active autoimmune disease disease also had poorer overall survival (HR = 2.81) possibly attributable to impaired T-cell activation owing to systemic immunosuppression.

“The findings of this cohort study suggest that safety and efficacy of ICIs are similar between patients with cancer with and without concurrent autoimmune disease diagnoses,” they concluded.

Novel TKI approved for NSCLC

Mobocertinib, a novel oral TKI that selectively targets EGFR harbouring exon 20 mutations in non-small cell lung cancer (NSCLC) has received TGA approval for use in the treatment of patients with locally advanced or metastatic NSCLC.

The drug, marketed by Takeda as Exkivity, is approved in patients who have an exon 20 insertion mutation of EGFR who have received prior platinum-based chemotherapy.

The TGA said the approval decision was made on the basis of objective response rate and duration of response in a single arm study.

Recently published in JAMA Oncology, a phase 1/2 study showed that mobocertinib was associated with clinically meaningful benefit in patients with previously treated EGFRex20ins-positive mNSCLC, and a favourable risk-benefit profile.

“Continued approval of this indication depends on verification and description of benefit in a confirmatory study,” the TGA said.

New radiotherapy option for pancreatic cancer patients

Epworth HealthCare in Victoria says it is the first private hospital group in Australia to offer a targeted radiotherapy pancreatic cancer treatment that may allow more patients to be eligible for surgery.

Patients with locally advanced tumours will be offered P32 radiation particles, which are injected into the tumour during an endoscopic ultrasound, according to

Associate Professor Andrew Metz, Director of the Jreissati Pancreatic Centre at Epworth.

“Over the next three months, the radiation particles give a really high, targeted dose of radiation just to the tumour,” he said.

“Just delivering the radiation into the tumour limits the effect to structures surrounding the pancreas, avoiding a whole lot of side effects.”

A/Prof Metz said early data indicated the treatment had a tumour-shrinking potential, increasing survival and enabling some patients, who have been inoperable, to have surgery.

“Until now, these patients would have undergone systemic chemotherapy if they are fit, with potential for many side effects,” he said.

The treatment Preliminary data about this new treatment shows a tumour-shrinking potential, increasing survival and enabling some patients, who have been inoperable, to have surgery.

The Epworth Medical Foundation is funding the treatment provided through the TGA Special Access Scheme for ten patients, at a cost of $100,000.

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