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Take a look at a selection of our recent media coverage:

Bispecific antibody glofitamab available on the NHS ‘within weeks‘ for advanced lymphoma

19th October 2023

The NHS will fast-track the bispecific antibody glofitamab (brand name Columvi) for treating relapsed or refractory (R/R) diffuse large B‑cell lymphoma (DLBCL) in adults after two or more systemic treatments following its recommendation by the National Institute for Health and Care Excellence (NICE).

Set to be made available in England ‘within weeks‘, glofitamab is the first off-the-shelf CD20xCD3 T-cell engaging bispecific antibody. Administered as an intravenous infusion, it works by encouraging healthy immune cells in the body to destroy the cancer cells.

While current DLBCL treatments such as CAR T therapies are provided in specialist centres across England, glofitamab can be offered at more cancer treatment sites across the country, improving timely access. It is thought that more than 700 people in England could benefit from the treatment.

NHS England’s Cancer Drug’s Fund Lead, Professor Peter Clark, said: ’The approval of this drug is great news for people living with an advanced and aggressive form of blood cancer, who are set to benefit from this new treatment.

’Not only does it provide a potentially life-saving option for patients who may have not responded to CAR T therapy, it is also an alternative for some CAR T eligible patients who choose instead to have glofitamab closer to home.

’This is the latest in a long list of cutting-edge drugs available on the NHS to help people with cancer live a longer and better-quality life.’

Helen Knight, director of medicines evaluation at NICE, added: ‘We are committed to getting the best care to patients fast while ensuring good value for the taxpayer.

‘Advanced B-cell lymphoma is an aggressive form of blood cancer and can progress quickly. The sooner people can access the best treatment for them, the better chance they have of living for longer and improving their quality of life.

‘This is why it is such good news that our independent committee has found that glofitamab is clinically and cost effective for treating people with this advanced form of cancer, and we welcome the news that NHS England will make this available to patients quickly.‘

Positive glofitamab trial results

The NICE recommendation coincides with glofitamab receiving its license by the Medicines and Healthcare products Regulatory Agency and is based on the positive results obtained from the Phase 1/2 NP30179 study.

Of the 154 participants who received treatment, 39% (95% confidence interval [CI], 32 to 48) had a complete response at a median follow-up of 12.6 months.

The majority (78%) of complete responses were ongoing at 12 months. The 12-month progression-free survival was 37% (95% CI, 28 to 46).

The most common adverse event was cytokine release syndrome (CRS) (63%). Adverse events of grade 3 or higher occurred in 62% of the patients, with grade 3 or higher CRS in 4% and grade 3 or higher neurologic events in 3%. Discontinuation of glofitamab due to adverse events occurred in 9% of the patients.

Referring to the rollout of bispecific antibodies as a breakthrough for patients with lymphoma, Dr Wendy Osborne, an NHS consultant haematologist specialising in lymphoma at the Freeman Hospital in Newcastle, said: ‘Bispecific antibodies use the patient’s own white blood cells to attack and kill the lymphoma, a form of blood cancer. The antibody has two arms: one arm attaches to the cancer cell and the other to the patient’s own white blood cell, a T-cell.

‘By bringing these cells together, the patient’s own immune system is activated and kills the cancer cell and so chemotherapy is not required. Patients don’t have the side effects of chemotherapy and often feel well on this outpatient-based treatment.‘

Glofitamab gained conditional marketing authorisation in the EU in July 2023.

Earlier in 2023, glofitamab was found to induce a fast and durable complete response rate in patients with refractory mantle cell lymphoma.

Glofitamab fast and effective in refractory mantle cell lymphoma

9th January 2023

Glofitamab therapy following obinutuzumab induced a fast and durable complete response rate in patients with refractory mantle cell lymphoma

Glofitamab therapy following obinutuzumab pre-treatment, led to a fast and durable complete response rate in patients with refractory or relapsed mantle cell lymphoma after the use of Bruton tyrosine kinase inhibitors according to a study presented at the American Society of Haematology (ASH) conference in in New Orleans, US.

Mantle cell lymphoma (MCL) is a rare, subtype of B-cell non-Hodgkin lymphomas characterised by a translocation resulting in over-expression of the cyclin D1 gene.  It develops from malignant B-lymphocytes within a region of a lymph node known as the mantle zone and largely affects men aged between 60 and 70 years of age, with around 1 in 200,000 diagnoses per year. The first-line treatment consists of intensive chemotherapy with autologous stem cell transplant for the fit or less intensive chemotherapy for less fit and transplant-ineligible individuals, although many eventually relapse with a progressive clinical course. Treatment with Bruton tyrosine kinase inhibitors such as ibrutinib is common although among ibrutinib-refractory MCL patients, there is a short survival. For example, one trial in 114 patients found that the median overall survival following cessation of ibrutinib was 2.9 months. 

Glofitamab is a T-cell-engaging bispecific antibody possessing a novel 2:1 structure with bivalency for CD20 on B cells and mono-valency for CD3 on T cells. In a phase 1 trial of patients with relapsed or refractory B-cell non-Hodgkin lymphoma, the drug showed favourable activity with frequent and durable complete responses and a predictable and manageable safety profile.

In the current study reported at ASH, patients were pre-treated with obinutuzumab 7 days prior to the first dose of glofitamab to mitigate the risk of cytokine release syndrome (CRS). Intravenous glofitamab step-up dosing was given on day 8 (2.5 mg) and 15 (10 mg) of the the first cycle, followed by a target dose of 16mg after 1000mg obinutuzumab or 30mg after 2000mg obinutuzumab, from the first day of the second cycle, then every 3 weeks for up to 12 cycles.

Glofitamab response rate

A total of 37 patients with a median age of 72 years (73% male) received glofitamab step-up dosing and of whom, 16 received pre-treatment with obinutuzumab 1000 mg. The majority (91.9%) had Stage III/IV disease and the median number of prior therapies was 3 with 64.9% having received a Bruton Kinase inhibitor. In addition, patients received glofitamab a median of 1.9 months after their last, treatment.

After a median follow-up of 8 months, overall response rate (ORR) and complete response (CR) rates were 83.8% and 73.0% respectively, across both obinutuzumab cohorts although the CR rate was higher with obinutuzumab 2000 mg (81% vs 62.5%). However, most impressive, was that across both cohorts, the median time to achieving a complete response was 51 days and an estimated 71.6% of patients with a CR remained in response at 9 months, with a median CR of 10 months.

In terms of safety, the most common adverse events were CRS (75.7%) and neutropenia (40.5%) although the CRS rates were lower with the higher dose of obinutuzumab (66.7% vs 87.5%). Neurologic adverse events occurred in 15.4% of all patients although none discontinued treatment due to adverse events.

The authors concluded that using a fixed-duration glofitamab monotherapy induced high and durable CR rates, the majority of which were achieved early, in heavily pretreated patients with MCL, most of whom had prior Bruton kinase inhibitor therapy and thus a particularly poor prognosis. 

Citation
Phillips TJ et al. Glofitamab Monotherapy Induces High Complete Response Rates in Patients with Heavily Pretreated Relapsed or Refractory Mantle Cell Lymphoma. Abstract No 74, ASH 2022

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