Merck has announced in the New England Journal 2022 edition a publication of results from the phase 3 Study 309/KEYNOTE-775 trial.

The study assessed the combination of Lenvima (lenvatinib) – a multiple receptor tyrosine kinase inhibitor administered orally as a pill, discovered by Eisai – with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) versus chemotherapy for patients with advanced, metastatic, or recurrent endometrial carcinoma following one prior platinum-based regimen. The study indicated that the chemotherapy used was down to the physician’s choice of either paclitaxel or doxorubicin.

Included in the journal publication was previously recorded data, originally presented at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer. The results presented demonstrated that the combination of Lenvima plus Keytruda showed statistically significant improvements regarding the dual primary endpoints of progression-free survival and overall survival, compared to chemotherapy.

The New England Journal 2022 contains results for the all-comer population, including the mismatch repair deficient (dMMR) patient population for which Lenvima plus Keytruda, has not yet been approved in the US.

Following the results taken from the phase 3 Study 309/KEYNOTE-775 trial, the combination of Lenvima and Keytruda has been given approval in the US for individuals living with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Gilead Sciences has shared that the US Food and Drug Administration (FDA) has placed a partial clinical hold on three phase 3 trials assessing the combination of magrolimab plus azacitidine used for patients with myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML) and AML patients unable to receive intensive chemotherapy.

The partial hold was also applied to earlier stage studies for MDS and myeloid malignancies. The company confirmed that six other phase 2 trials would go ahead as previously planned and also stated that tests evaluating magolimab in isolation, without azacitidine or in combination with other drugs, remain unaffected by the latest decision.

Gilead said that the partial hold on the clinical trials was due to the FDA’s decision to act in the interest of patient safety, with concerns over an apparent imbalance in reported suspected unexpected serious adverse reactions (SUSARs) between branches of the study.

Despite the company being unable to identify any specific adverse reactions or negative safety markers, it has been decided that the partial clinical hold will be implemented by Gilead companywide regarding all ongoing combination studies of magrolimab and azacitidine.

Gilead is in the process of gathering additional data analyses in order to address the issues raised by the FDA, alongside company efforts to notify clinical investigatory teams and regulatory authorities worldwide about the clinical hold.

Pfizer has announced that the US Food and Drug Administration (FDA) has granted approval for Cibinqo (abrocitinib) for the treatment of refractory, moderate-to-severe atopic dermatitis in adults whose disease is not managed with other therapies.

Cibinqo is a once-daily, oral Janus kinase 1 (JAK1) inhibitor used in adult patients living with moderate-to-severe atopic dermatitis who have not yet found relief in currently available treatment options, or for patients advised against using current treatments.

Atopic dermatitis is a chronic, debilitating skin condition characterised by skin inflammation and skin barrier irregularities. The condition is brought about, in part, by the individual’s abnormal immune response beneath the skin which is believed to contribute to inflammation within the skin, presenting with typical signs of atopic dermatitis on the surface.

Characterisations of atopic dermatitis include itching, thick or leathery skin, papulation and erythema, where patches of skin become discoloured.

The FDA based its approval on the results gained from five clinical trials as part of a larger clinical trial programme involving more than 1,600 patients. The safety and effectiveness of Cibinqo was assessed in three randomised, placebo-controlled phase 3 trials, with the drug demonstrating a consistent safety profile.

Moreover, the results showed a profound improvement in skin clearance and a significant reduction in itching after a two-week period for atopic dermatitis patients versus placebo.

After forming a partnership to develop a multiple myeloma CAR-T cell therapy, Bristol Myers Squibb (BMS) and 2seventy bio have announced that the development plans have been scrapped, while sales for BMS’ Abecma continue to grow.

The collaboration, which began in 2017, was focused on a trial to evaluate treatments for patients with relapsed or refractory multiple myeloma.

2seventy bio – a spin-out of bluebird bio, to facilitate its oncology portfolio – confirmed that further developments for the therapy known as bb21217 would cease, following results from an ongoing phase 1 study.

The company maintains that it plans to ‘leverage the learnings from this programme to further strengthen its oncology pipeline’.

This cancellation is the second anti-BCMA CAR-T programme to be halted under BMS in the last twelve months, after a development programme with Juno Therapeutics was scrapped in February 2021.

Abecma, approved in March 2021 as the first BCMA CAR-T programme, is a fourth-line or later treatment for patients with multiple myeloma. BMS has major plans to expand the drug’s capabilities, with phase 3 data for a third line expected sometime in the next eighteen months, while proof-of-concept data for second-line patients is expected by the end of this year.

In its third quarter update, BMS announced that sales for Abecma had grown from $24m in its second quarter to $71m in its third quarter.