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Roche Forecasts Alecensa Growth Following Strong Data Readout in Adjuvant Lung Cancer

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NEW YORK – Roche on Thursday said it will seek regulatory approval for the ALK inhibitor Alecensa (alectinib) as an adjuvant treatment for early-stage ALK-positive non-small cell lung cancer based on results from a Phase III trial.

Researchers will report full data from the ALINA trial at the upcoming European Society for Medical Oncology Congress. Ahead of the conference, the company announced that Alecensa reduced the risk of disease recurrence or death by 76 percent in the study compared to platinum-based chemotherapy in early-stage NSCLC patients who had their tumors surgically resected. Furthermore, patients with central nervous system metastases who received the drug had clinically meaningful improvements in disease-free survival compared to those on chemo.

Roche also released its third quarter financial results on Thursday. Roche Group CEO Thomas Schinecker said in a conference call discussing the results that overall sales for the three months ended Sept. 30 grew 7 percent at constant exchange rates. Roche Group reported CHF 14.27 billion ($15.96 billion) in overall sales in Q3 compared to CHF 14.74 billion for the same quarter in 2022. Revenues from the Swiss drugmaker's pharmaceuticals division increased 11 percent at CER to CHF 10.94 billion compared to CHF 10.84 billion in Q3 2022. Roche's diagnostics revenues fell 5 percent at CER to CHF 3.33 billion from CHF 3.90 billion a year ago. Schinecker attributed the lower revenues to declining COVID-19 test sales, which he predicted would last two more quarters.

During the call, Roche executives provided updates on several precision oncology products, including Alecensa, which contributed CHF 368 million in Q3 2023, a 7 percent increase at CER from Q3 2022. Alecensa was approved in 2017 as a treatment for patients with metastatic ALK-positive metastatic NSCLC, but Roche and subsidiary Genentech are interested in advancing the drug as an adjuvant treatment for early-stage disease.

Standard first-line therapy for early-stage ALK-positive NSCLC is platinum-based chemotherapy. There are few targeted precision oncology drugs approved in the adjuvant setting. In December 2020, the US Food and Drug Administration approved the first such drug, AstraZeneca's Tagrisso (osimertinib), as an adjuvant treatment for EGFR-mutated NSCLC.

Roche is now attempting to demonstrate Alecensa's potential as an adjuvant treatment for the subset of NSCLC patients with ALK rearrangements in the ALINA trial, in which investigators compared Alecensa to intravenous chemotherapy in 257 patients with stage IB to IIIA NSCLC following surgical resection of their cancers.

"These are really just breathtaking results," Roche Pharmaceuticals CEO Teresa Graham said in the call about the results from ALINA. She estimated that Roche will bring in around $500 million in additional sales a year from this new Alecensa indication if it is approved in the US and EU next year.

"About 45 percent of patients that we believe will be eligible for this drug will actually get tested early enough to take advantage of treatment in the adjuvant setting," Graham said.

Alecensa sales can increase even more, she added, if the Phase III HORIZON trial in unresectable ALK-positive NSCLC and the tumor-agnostic Phase II TAPISTRY trial are successful.

Roche's oncology portfolio grew 5 percent at CER for the first nine months of 2023 to CHF 14.5 billion compared to the same period in 2022. Graham said on the call that revenue in this segment during the quarter was up 1 percent at CER from the half-year mark.

The PD-L1 inhibitor Tecentriq (atezolizumab) recorded CHF 938 million in sales in Q3 2023, compared to CHF 934 million in Q3 2022, a 10 percent increase at CER. In the third quarter, Roche garnered approval of a subcutaneous formulation of the immunotherapy, dubbed Tecentriq SC, in Great Britain and has recently dosed the first patient with it outside of a clinical trial. Graham compared the product to Roche's fixed-dose combination Phesgo, a subcutaneous injection comprising Perjeta (pertuzumab), Herceptin (trastuzumab), and hyaluronidase for HER2-positive breast cancer. "[Tecentriq SC] reduces administration time to seven minutes from a 30-to-60-minute infusion," Graham said, "We would expect similar adoption to what we have seen with Phesgo."

Within Roche's HER2 franchise, Perjeta sales were CHF 913 million in Q3 2023, compared to CHF 1.02 billion in the year-ago quarter, nearly flat year over year at CER. Kadcyla (trastuzumab emtansine) sales during the same period grew 5 percent at CER to CHF 485 million compared to CHF 516 million, while Phesgo sales grew 61 percent at CER to CHF 300 million in compared to CHF 201 million.

Graham said Roche is continuing to convert patients from Perjeta to Phesgo at a strong rate. "We are at 20 percent [conversion] now in the US," she said. "We expect Phesgo to achieve blockbuster status by the end of the year, and our ambition is to reach a 50 percent conversion rate for Phesgo in the coming years."

Given that Roche doesn't expect the first biosimilar for Perjeta to enter the market until 2026, "we have some fairly good runway there," Graham added.

Roche confirmed its previously announced 2023 financial outlook. As sales of Roche's COVID-19 products are expected to decline by roughly CHF 4.5 billion and sales of Avastin (bevacizumab), Herceptin, and Rituxan (rituximab) are projected to decrease by about CHF 1.1 billion due to biosimilar competition, Roche is expecting a low-single-digit decline in group sales in 2023 at CER.