Promising data for lung cancer drug AZD9291 bolsters AstraZeneca's upbeat pipeline view


 

May 15, 2014 | By Joe Barber

 

AstraZeneca released clinical data ahead of the ASCO annual meeting on a number of experimental drugs, including promising early-stage results for AZD9291 in patients with EGFR mutation positive non-small-cell lung cancer (NSCLC). CEO Pascal Soriot remarked "we are encouraged by the progress in the development of key assets," adding "we have complete confidence in our strategy as an independent company and remain focused on delivering new medicines for patients, which will continue to create significant value for our shareholders."

 

The drugmaker has highlighted its pipeline, particularly its experimental cancer drugs, as it looks to resist takeover attempts from Pfizer, most recently rejecting an offer valued at 63 billion pounds ($106 billion) as inadequate. "ASCO is important but it’s one step," Soriot commented, adding "we hope as we progress this year, investors will become more convinced there is more value in this company than what is offered to us."

 

The findings from the AURA study showed that AZD9291 shrank tumours in 51 percent of 199 patients with EGFR mutation positive NSCLC who have developed acquired resistance to EGFR tyrosine-kinase inhibitors (TKIs). Results demonstrated that the experimental agent shrank tumours in 64 percent of patients found to have the T790M mutation, while in those without the mutation, the response rate was 23 percent. "Although it is still a bit early, our study suggests that AZD9291 may offer an effective new therapy option for these patients," without side effects seen from other similar treatments, said lead author Pasi Janne (for related analysis, read ViewPoints: ASCO data dump falls in AstraZeneca's favour but Clovis battle looms).

 

AstraZeneca is currently conducting a Phase II study of AZD9291 in patients with the T790M mutation, which it noted could enable an accelerated regulatory filing in the second half of next year. The company also plans to initiate late-stage trials of the therapy, which was recently granted breakthrough therapy status by the FDA for patients with metastatic EGFR T790M mutation-positive NSCLC, whose disease has progressed following treatment with an EGFR TKI. If approved, the drugmaker predicts that AZD9291 could generate sales of $3 billion, while Leerink Partners analyst Seamus Fernandez estimates revenue of more than $2.2 billion by 2025.

 

Panmure Gordon analyst Savvas Neophytou called the data for AZD9291 impressive, adding "AstraZeneca's management is right to be excited by the pipeline" (for related analysis, read ViewPoints: Bullish outlook for pipeline designed to reverse decade long malaise at AstraZeneca). The company also indicated that it will present Phase I data for its experimental lung cancer therapy MEDI4736 at ASCO, which it said has so far shown "durable clinical activity and acceptable safety." Earlier this month, AstraZeneca disclosed details of a Phase III programme for the anti-PD-L1 immune checkpoint inhibitor in NSCLC, while the company recently announced plans to pair the agent with Incyte's oral IDO1 inhibitor INCB24360 in Phase I/II trials for several indications, including metastatic melanoma. AstraZeneca predicts peak sales of $6.5 billion for the immunotherapy, compared to analyst projections of $2 billion to $7 billion.

 

At the ASCO meeting, the company will also highlight mid-stage study data for the combination of the VEGF inhibitor cediranib and the PARP inhibitor olaparib for the treatment of high-grade serous ovarian cancer. The drugmaker expects peak annual sales of $2 billion for olaparib, in line with analyst expectations of $1.5 billion to $3 billion. AstraZeneca also highlighted other recent pipeline updates, including positive Phase III results for the combination of saxagliptin and dapagliflozin in patients with type 2 diabetes inadequately controlled on metformin, as well as late-stage data for the psoriasis therapy brodalumab, which is partnered with Amgen (for related analysis, see ViewPoints: Amgen co-development data provides timely fillip for AstraZeneca).

 

Fernandez said "AstraZeneca’s recent series of data releases highlights what we continue to believe is one of the best mid- to late-stage pipelines within all of biopharma." The analyst suggested that the company is also likely to pair AZD9291 with MEDI4736 in a combination trial that has a "strong scientific rationale." Meanwhile, Credit Suisse analyst Vamil Divan suggested that positive data at the ASCO conference could prompt Pfizer to increase its offer for AstraZeneca. "It could bump up the interest level by Pfizer a little bit, or the price a little bit," Divan remarked. Pfizer recently indicated a willingness to amend its offer if AstraZeneca would enter talks.

 

Divan noted that AstraZeneca could also benefit if other companies present positive data at ASCO for experimental immuno-oncology therapies outside of lung cancer and melanoma. "The whole meeting is going to be very immune-oncology-heavy, and we’ll get a sense of the potential of this class of agents," Divan commented, adding "if it does look like that class is big, that bodes well for [AstraZeneca]." For related analysis, see Spotlight On: The great immuno-oncology race – can everyone be a winner?

 

Sources: FirstWord PHARMA

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