German watchdog calls for direct comparison of cancer immunotherapies

FRANKFURT: Germany’s drug assessment body has criticized a lack of data directly comparing drugs in a promising new class of cancer immunotherapy, saying physicians could be overwhelmed or misled by the available information.

IQWiG, the independent authority in Germany that evaluates new drugs and plays a key role in what price health services pay for them, has looked into new immunotherapy drugs for the treatment of bladder cancer as part of its so-called early benefit assessment.

It concluded there were some signs that patients who could not be helped by previous courses of standard chemotherapy could benefit considerably from Merck & Co’s Keytruda and Roche’s Tecentriq, but said physicians needed head-to-head drug trials to pick the best treatment option.

“The procedure of the early benefit assessment does unfortunately not allow a comparison of new drugs against each other,” IQWiG Director Juergen Windeler said in a statement.

“Such a measure appears to be almost indispensable in the case of urothelial (bladder) carcinoma: We now have three drugs for the same therapeutic indication, but are unable to reasonably relate the assessment results to each other.”

When several new drugs in the same class hit the market in quick succession they are typically compared to older treatment standards in drug trials and not against each other.

Having secured regulatory approval, companies tend to shun follow-on trials that go head-to-head with new competitors because of the high costs involved and because it jeopardizes a hard-won market opportunity.

But IQWiG said regulations should be changed so that companies are required to conduct such studies as IQWiG does not have the mandate to do so.

The class of so-called checkpoint inhibitors that help unmask cancer cells hiding from the body’s immune system also includes Bristol-Myers Squibb’s Opdivo and AstraZeneca’s Imfinzi, as well as Merck KGaA and Pfizer’s Bavencio, targeting a broad range of cancer types.

IQWiG has been critical for years of what it described as insufficient trial data on new drugs, rejecting some pivotal studies that had convinced the European Medicines Agency to approve a drug.

This has resulted in some drugs not getting launched in Germany, Europe’s largest pharma market, or being withdrawn soon after their launch.