TNBC treatment adds newly approved immunotherapy option

Tecentriq applies for reimbursement listing last month with new approval

The U.S. FDA approves Keytruda, adding PD-1 inhibitor option

Anticipation is heightening for the use of an immunotherapy Tecentriq (atezolizumab) in the triple-negative breast cancer (TNBC) treatment scene.

 

Pharmaceutical industry sources reported Roche Korea’s PD-L1 inhibiting immunotherapy Tecentriq has recently successfully expanded the indication as a first-line treatment for TNBC, combined with nanoparticle albumin-bound (nab) paclitaxel, in the U.S.

 

and now in South Korea.

 

Moreover, the U.S.

 

health authority also additionally indicated the drug to treat the disease in combination with Merk’s PD-1 inhibiting chemotherapy Keytruda (pembrolizumab) as a first-line treatment.

 

The medical scene is closely following the news with an anticipation of opening more practical options of immunotherapy in TNBC treatment area currently lacking a variety of options.

 

Since Roche Korea submitted the National Health Insurance (NHI) reimbursement application last month, the South Korean health authority is currently in process of reviewing the coverage on Tecentriq.

 

However, it is still unknown how long the listing procedure would take.

 

Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government after the company accepted the condition to cover the initial administration cost.

 

However, Roche has not commented if it would take the same condition for the expanded coverage.

 

In the Phase III IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression-free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone.

 

Keytruda has even longer way to go.

 

Although there is no apparent barrier yet, the drug’s reimbursement expansion for the first-line lung cancer treatment has been sluggish so far.

 

In the KEYNOTE-355 study, evaluating PFS in patients with locally recurrent unresectable or metastatic TNBC, the Keytruda combination therapy resulted in statically meaningful improvement in reducing the risk of disease progression or death by 35 percent through a first-line treatment in patients, who had not been previously treated with chemotherapy and the expression of tumor PD-L1 was over CPS 10.

 

The mPFS in the Keytruda combination therapy group marked 9.7 months, when the chemotherapy-only group reached 5.6 months.

 

To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet.

 

For a long time, chemotherapy was the only option for patients with TNBC.

 

Roche’s targeted therapy Avastin (bevacizumab) still remains as a non-reimbursed option, although it was the first one to win the indication in South Korea.

 

But the selection of TNBC treatment options has been widened recently with a poly ADP ribose polymerase (PARP) inhibiting targeted therapy Lynparza (olaparib) and other immunotherapy added to the market.