dm+d

34881111000001104

Refrigerated Storage

BavencioMerck - Pfizer

Merck - Pfizer
Bavencio
Concentrate for solution for infusion, 20mg/ml

Contact Merck – Pfizer in all cases where a deviation from the recommended storage conditions has occurred.

Please refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

3 February 2022
London MI Service

New Medicines

BavencioLocally advanced or metastatic urothelial cancer - first-line maintenance therapy patients who do not worsen during or following completion of first-line platinum-based chemotherapy

Information

Bavencio
Licence extension / variation
Merck KGaA & Pfizer
Merck KGaA & Pfizer

Development and Regulatory status

Launched
Launched
Launched
January 2021
Jan 21Also approved in the UK [15].
Jan 21Approved in EU [14].
Dec 20Recommended for EU approval by CHMP - the additional indication is "as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy" [13].
Sep 20Granted Early Access to Medicines Scheme (EAMS) status in UK by MHRA for treatment of adults with bladder cancer that has spread beyond the bladder (advanced urothelial carcinoma) if the cancer did not get worse after chemotherapy [11].
Jul 20Approved in US [10].
Jun 20Filed in EU [9].
Apr 20sBLA filed in US for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma. Application is based on positive results from interim analysis of PIII JAVELIN Bladder 100 trial [7].
Apr 20Granted Breakthrough Therapy designation by the FDA in the US [8]
Jun 18Will be filed in EU using centralised procedure [2].

Category

Anti PD-L1 antibody
UK incidence of bladder cancer is 11.4 per 100,000 population. The vast majority of bladder cancers in the UK are transitional cell carcinomas (also known as urothelial cell carcinomas). The recurrence rate for superficial transitional cell cancer of the bladder is high (70% within five years). As many as 80% of pts have at least one recurrence [1].
Locally advanced or metastatic urothelial cancer - first-line maintenance therapy patients who do not worsen during or following completion of first-line platinum-based chemotherapy
Intravenous infusion

Further information

Yes

Trial or other data

Sep 20PIII JAVELIN Bladder 100 trial (NCT02603432) is published; in patients without disease progression following first-line chemotherapy (n=700), the addition of maintenance avelumab to best supportive care was associated with prolonged overall survival (median 21.4 vs. 14.3 months; HR 0.69; 95% CI 0.56 to 0.86; P=0.001) [12].
Jan 20PIII JAVELIN Bladder 100 trial meets primary OS endpoint at planned interim analysis [6].
Nov 19PIII JAVELIN Bladder 100 trial (NCT02603432) has finished recruiting & is now due to complete collection of primary outcome data in Jun 20 [5].
Jun 18PIII JAVELIN Bladder 100 trial (NCT02603432) is still recruiting; timescales unchanged [4].
Dec 15PIII JAVELIN Bladder 100 trial, to compare the efficacy of maintenance treatment with avelumab IV infusion q2w plus best supportive care (BSC) with BSC alone in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy starts (NCT02603432). Overall survival up to approximately 40 months will be assessed as the primary endpoint. The global trial is enrolling 668 patients (incl. in UK). Collection of primary outcome data due to complete Jul 19 [2,3].

Evidence based evaluations

BavencioPD-L1-positive non-small cell lung cancer (NSCLC) - first-line

Information

Bavencio
Licence extension / variation
Merck KGaA & Pfizer
Merck KGaA & Pfizer

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Mar 22Removed from Merck pipeline; presume development has been discontinued [19].
Feb 22Pfizer announces that Bavencio had shown clinical activity but failed to beat chemo on the OS and PFS co-primary endpoints in JAVELIN Lung 100 study. In the changing NSCLC environment it is possible that control cohort patients went on to receive efficacious anti-PD-(L)1 therapy, including Keytruda, but it is increasingly looking as though Bavencio simply is not a particularly good drug. JAVELIN had twice been enlarged, was refocused on PD-L1 expressers and had its primary endpoints overhauled. But protracted delays – readout had originally been expected April 2019, before being put back four times – meant that Keytruda has become standard of care while Javelin ’s results receded into near irrelevance [18].

Category

Anti PD-L1 antibody
More than 39,000 new cases of lung cancer are diagnosed in the UK each year. NSCLC accounts for 85% of cases [2].
PD-L1-positive non-small cell lung cancer (NSCLC) - first-line
Intravenous

Further information

Yes