White blood cells

Credit: LRI EM Unit

The National Insititute of Health and Care Excellence (NICE) has recommended a new chemotherapy free treatment option for some adults with untreated chronic lymphocytic leukaemia (CLL).

The targeted treatment combo of venetoclax (Venclyxto) plus obinutuzumab (Gazyvaro) will now be available for some adults with CLL on the NHS in England. The new treatment will be offered to people with untreated CLL as a fixed 12-month chemotherapy-free option.

CLL is a type of blood cancer that affects white blood cells. It accounts for around 30% of all leukaemia’s affecting adults. In England there was an average of 3,800 new cases of CLL per year between 2015 and 2017.

NICE estimates that around 1,000 people each year could benefit from this new treatment option.

Who could benefit from the new combo?

Venetoclax is currently used as a combination treatment option on the NHS in both Scotland and England for people with CLL who have had at least one previous therapy.

Generally, people with untreated CLL are offered different treatments depending on whether their leukaemia has certain genetic markers, such as a 17p deletion or a TP53 mutation, and how likely they are to tolerate combinations involving chemotherapy.

For people with one of these two genetic markers, CLL does not usually respond well to standard chemo-immunotherapy combinations, and the targeted drug ibrutinib (Imburvica) is usually used instead.

Venetoclax plus obinutuzumab will now provide an additional option for these people.

For patients with untreated CLL who don’t have one the genetic markers, venetoclax plus obinutuzumab will be offered if other treatment options aren’t suitable.

Finally, NICE has approved the venetoclax combo for people without either of the genetic faults and who are able to take standard chemotherapy options via the Cancer Drugs Fund while more evidence is gathered on its effectiveness in this group.

Clinical trial results

Venetoclax plus obinutuzumab has not been directly compared to ibrutinib in people whose CLL has the genetic markers in clinical trials.

Clinical trial evidence found that for people with CLL without a 17p deletion or TP53 mutation who can’t take chemo-immunotherapies, venetoclax plus obinutuzumab increased the time taken for the cancer to get worse compared with obinutuzumab plus chlorambucil.

At a median follow up of 39.6 months, too few patients on the venetoclax plus obinutuzumab combo had seen their cancer get significantly worse to gather data on how long the combo can delay cancer progression. This is compared to an average of 35.6 months before the cancer got significantly worse for patients in the chlorambucil and obinutuzumab group.

An ongoing clinical trial is directly comparing venetoclax plus obinutuzumab with existing chemo-immunotherapies in people with untreated CLL without a genetic marker, for whom these treatments are suitable. Data from this trial could help address the uncertainty about the clinical effectiveness of venetoclax plus obinutuzumab in this population.

NICE agreed that there is an unmet need for an effective, time-limited treatment with fewer side effects than existing treatments available in the NHS in England. NICE also agreed that the venetoclax plus obinutuzumab combination is generally well tolerated. The committee therefore decided to add this treatment combo to the Cancer Drugs Fund.

NICE decisions are usually adopted in Wales and Northern Ireland as well as England, so the drug combination should now be available to patients in all 3 nations. Scotland has a separate process for reviewing drugs.

References

NICE (2020) Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia [ID1402]