Novartis heads to FDA after lung cancer combo clears pivotal trial


Novartis ($NVS) is gearing up to submit its Tafinlar-Mekinist combination for approval in lung cancer. Confirmation of the filing plan, which could see lung cancer join melanoma on the list of indications the combination is approved in, follows the release of data from a pivotal Phase II trial in which the treatment was associated with an overall response rate of 63%.

The single-arm, open-label trial gave the combination to 57 metastatic non-small cell lung cancer (NSCLC) patients who had gone through at least one line of chemotherapy and had the rare BRAF V600E mutation, a genetic change that is associated with particularly poor prognoses. In this hard-to-treat subpopulation, the Tafinlar-Mekinist combination triggered a clinical response in 63% of participants. Median duration of response and progression-free survival clocked in at 9.0 months and 9.7 months, respectively.

Novartis sees these outcomes as comparing favorably to what can be achieved by chemotherapy. “We are talking about a response rate that is in the 60% ballpark, [with] progression-free survival that is approaching 10 months--never seen in the past with chemotherapy", Alessandro Riva, global head of oncology development at Novartis, told Reuters. “Chemotherapy ... has a progression-free survival that is not more than two or three months.”

Patients in the trial suffered from some severe side effects--8 participants dropped out because of adverse events--but the results have nonetheless encouraged Novartis to step up preparations to submit for approval in the U.S. Riva is aiming to have a filing in front of FDA some time after July. If successful, the 1-2% of NSCLC patients who are BRAF V600E-mutation positive would gain access to a new treatment option.

“The potential to treat this oncogene gives hope to a very small, underserved patient population,” Dr. David Planchard, the trial's principal investigator, said.

For Novartis, the approval would give it another indication in which to sell the combination, which is up against Roche’s ($RHHBY) Zelboraf-Cotellic product in BRAF V600 melanoma. Novartis picked up the assets last year as part of its deal with GlaxoSmithKline ($GSK).

- read the ASCO abstract
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