Amgen’s Lung Cancer Therapy Wins Breakthrough Designation In China

Amgen announced on Jan. 29 that its experimental lung cancer drug, sotorasib, has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation in China.

The BTD designation was granted for patients with metastatic non-small cell lung cancer (NSLC) and who have received at least one systemic therapy before. The BTD means that in China, sotorasib could become the first targeted treatment for non-small cell lung cancer. The Center for Drug Evaluation is part of the National Medical Products Administration (NMPA).

According to Amgen (AMGN), non-small cell lung cancer is the most common form of lung cancer that accounts worldwide for 80% to 85% of all cases. This was the first BTD submission for the biopharma company in China under the company’s collaboration with BeiGene.

David M. Reese, EVP of R&D at Amgen commented, “Given that Breakthrough Therapy Designation is a new pathway in China, we are pleased to receive this designation for sotorasib. This designation underscores the importance of sotorasib and we look forward to working with regulatory authorities in China to bring the first potential targeted therapy to NSCLC patients with the KRAS G12C mutation.”

The Chinese drug authority’s approval comes as the company’s Phase 2 study for sotorasib showed positive results and the drug was found to be effective for NSLC. (See Amgen stock analysis on TipRanks)

On Jan. 29, Credit Suisse analyst Evan Seigerman reiterated a Buy rating and a price target of $280 on the stock.

Seigerman commented on the Phase 2 study of sotorasib, saying that “the ORR [overall response rate] of 37% is similar to the 35.3% reported in Phase 1 on an ‘all comers’ basis, and should be good enough to continue competing with Mirati’s ~45% for Adagrasib that was provided from pooled Phase 1/2 data (on an arguably modified ITT [intention to treat] basis).”

“We are encouraged that 3 patients experienced a complete response–suggesting deep responses in some patients. Safety continues to look acceptable with most treatment-related adverse events (TRAEs) classified as mild-to-moderate and no treatment related deaths.” Seigerman added.

The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus rating. That’s based on 9 analysts recommending a Buy and 7 analysts suggesting a Hold. The average analyst price target of $270.17 implies 11.9% upside potential to current levels. Shares fell 2.5% to $241.43 on Jan. 29.

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