New treatment option for MCL on PBS

Acalabrutinib (Calquence) is now PBS-listed for relapsed and/or refractory mantle cell lymphoma (R/R MCL).

As previously reported in the limbic, the PBAC recommended the listing of acalabrutinib  for people with R/R MCL who have received at least one prior therapy and have a WHO performance status of 0 or 1.

The PBAC considered that acalabrutinib should be available to BTK inhibitor-naïve patients or patients who have developed an intolerance to another BTK inhibitor necessitating permanent treatment withdrawal.

Minister for Health and Aged Care, Greg Hunt, said more than 350 Australians with MCL accessed a similar treatment through the PBS in 2020.

“The listing of Calquence will provide Australians with an alternate treatment option for this condition,” Minister Hunt said.

“Without PBS subsidy, Australians could pay more than $8,200 per script, instead, they can access it for $42.50 per script or just $6.80 for people with a concession card.”

DLBCL treatment response predicted by ctDNA

Circulating tumour DNA levels demonstrate independent prognostic value for survival in patients with R/R DLBCL.

The study was conducted in a cohort of adults with R/R DLBCL being treated with polatuzumab vedotin in combination with bendamustine (B) and rituximab (R) or BR alone.

Baseline ctDNA was detected in all available samples and the median number of variants detected by the assay was 133.

ctDNA mutant molecules per mL (MMPM) correlated with known prognostic factors including serum LDH levels, number of prior therapies and IPI score.

Higher baseline ctDNA were associated with a shorter PFS (HR 0.14) and OS (HR 0.19) while changes in ctDNA over time also correlated with patient response at end of treatment.

“As the utility of ctDNA in R/R DLBCL is further validated and ctDNA analyses become more refined with faster turnaround and standardised thresholds, it may be possible to use real-time, ctDNA-based interventions to predict responses during treatment with potential to switch from an unsuccessful therapeutic strategy at an earlier timepoint,” the researchers said.

Read more in Blood Advances

hIVIG not effective against COVID-19

Hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2 has failed to show efficacy in hospitalised patients with COVID-19 without end-organ failure.

The RCT of 593 adult patients from 63 sites across 11 countries compared hIVIG versus placebo in patients treated with remdesivir, when not contraindicated, and other standard clinical care.

“The OR for being in a more favourable outcome in the hIVIG group compared with placebo on day 7 was 1·06 (95% CI 0·77–1·45; p=0·72).”

“When comparing the day 7 ordinal category with baseline ordinal category, 184 (63%) of 293 participants in the hIVIG group and 179 (64%) of 279 in the placebo group were in a better category; 44 (15%) and 50 (18%), respectively were in a worse category.”

“Overall, these findings indicate that hIVIG confers no clinical benefit for hospitalised patients with COVID-19.”

Together with the lack of efficacy of convalescent plasma, it seems passive immunotherapies for COVID-19 have not lived up to expectations.

Read more in The Lancet